TYLENOL Tablets, Capsule, Suspension, Powder Ref.[50413] Active ingredients: Paracetamol

Source: Health Products and Food Branch (CA)  Revision Year: 2021 

Product name

TYLENOL Regular Strength (DIN 00559393): Acetaminophen Tablets USP 325 mg.
TYLENOL Regular Strength Caplets (DIN 00723894): Acetaminophen Tablets USP 325 mg.
TYLENOL Extra Strength (DIN 00559407): Acetaminophen Tablets USP 500 mg.
TYLENOL Extra Strength Caplets (DIN 00723908): Acetaminophen Tablets USP 500 mg.
TYLENOL Liquid Gels (DIN 02407612): Acetaminophen Capsule 325 mg.
TYLENOL Rapid Release (DIN 00863270): Acetaminophen Tablets USP 500 mg.
TYLENOL Arthritis Pain 8 (DIN 02238885): Acetaminophen Tablets (Extended Release) 650 mg.
TYLENOL Muscle & Body (DIN 02246060): Acetaminophen Tablets (Extended Release) 650 mg.

Children’s TYLENOL Chewables (02241361): Acetaminophen Tablets USP 160 mg (Bubblegum and Grape).
Children’s TYLENOL Fastmelts (DIN 02347792): Acetaminophen Tablets USP 160 mg (Grape).
Children’s TYLENOL (DIN 02046040): Acetaminophen Suspension USP 160 mg/5 mL (Banana Berry, Bubblegum, Grape, Dye-Free Cherry and Dye-Free Berry).
Infants' TYLENOL (DIN 02046059): Acetaminophen Suspension USP 80 mg / 1 mL (Cherry and Dye-Free Grape).
Children’s TYLENOL Easy Dissolve (DIN XXXXXXXX): Acetaminophen Powder 160 mg (Wild Berry).

Summary product information

Table 1. Product Information:

Route of AdministrationDosage Form/StrengthClinically Relevant
Inactive Ingredients
OralSuspension / 80 mg/1 mLAlcohol-, gluten-, lactose-, sucrose-, sulfite- and tartrazine-free
For a complete listing of inactive ingredients, see “Dosage Forms, Composition and Packaging” section
OralSuspension / 160 mg/5mLAlcohol-, gluten-, lactose-, sucrose-, sulfite- and tartrazine-free
For a complete listing of inactive ingredients, see “Dosage Forms, Composition and Packaging” section
OralTablet / 160 mgFastmelts: Gluten-, sucrose- and tartrazine-free; contains lactose For a complete listing of inactive ingredients, see “Dosage Forms, Composition and Packaging” section
OralTablet / 160 mgChewables (grape; bubblegum): aspartame-gluten-, lactose and tartrazinefree; contains dextrose. For a complete listing of inactive ingredients, see “Dosage Forms, Composition and Packaging” section
OralTablet, Caplet and Liquid Gel Capsule / 325 mgGluten-, lactose- and tartrazine-free
For a complete listing of inactive ingredients, see “Dosage Forms, Composition and Packaging” section
OralTablet, Caplet and Gelcap / 500 mgGluten-, lactose- and tartrazine-free
For a complete listing of inactive ingredients, see Dosage Forms, Composition and Packaging section
OralCaplet / 650 mg (325 mg Immediate Release/325 mg Extended Release) Gluten-, lactose- and tartrazine-free
For a complete listing of inactive ingredients, see Dosage Forms, Composition and Packaging section
OralPowder / 160 mg per PackSucrose-free; contains sucralose and xylitol For a complete listing of inactive ingredients, see Dosage Forms, Composition and Packaging section

Dosage forms, composition and packaging

Adults

Tablets

TYLENOL Regular Strength (325 mg Tablets): Each round, white tablet, engraved “TYLENOL” on one side and “325” on the other side, contains: acetaminophen 325mg. Inactive ingredients: cellulose, corn starch, magnesium stearate and sodium starch glycolate.Vials of 12 and plastic bottles of 24, 50, 100.

TYLENOL Extra Strength (500 mg eZ TABS/Tablets): Each round, red, sweetcoated tablet, printed “TYLENOL 500” contains: acetaminophen 500 mg. Inactive ingredients: carnauba wax, cellulose, corn starch, FD&C red no. 40, FD&C yellow no. 6, hypromellose, iron oxide black, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, stearic acid, sucralose, titanium dioxide. Plastic bottles of 24, 50, 100, 150, 200. See next entry for vials.

TYLENOL Extra Strength (500 mg eZ TABS/Tablets): Each round, red, sweetcoated tablet, printed “TYLENOL 500”, contains: acetaminophen 500 mg. Inactive ingredients: carnauba wax, cellulose, corn starch, FD&C red no. 40, FD&C yellow no. 6, hypromellose, iron oxide black, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, sucralose, titanium dioxide. Vials of 10.

Caplets

TYLENOL Regular Strength Caplets (325 mg): Each elongated, capsule-shaped white tablet, engraved “TYLENOL” on one side and “325” on the other side, contains: acetaminophen 325 mg. Inactive ingredients: cellulose, corn starch, hypromellose, magnesium stearate, polyethylene glycol and sodium starch glycolate. Plastic bottles of 24, 50, 100 and 200.

TYLENOL Extra Strength Caplets (500 mg): Each elongated, capsule-shaped white tablet, engraved “TYLENOL” on one side and “500” on the other side, contains: acetaminophen 500 mg. Inactive ingredients: cellulose, corn starch, hypromellose, magnesium stearate, polyethylene glycol and sodium starch glycolate. Vials of 10 and plastic bottles of 24, 50, 100 and 150.

Liquid Gel Capsules

TYLENOL Liquid Gels (325 mg liquid-filled capsules): Each red liquid capsule is printed with “TY 325” on one side in white ink, contains: acetaminophen 325 mg. Inactive ingredients: ascorbyl palmitate, caprylic/capric triglycerides, dl-α-tocopherol, FD&C red no. 40, gelatin, glycerin, lecithin, medium chain triglycerides, monodiglycerides, oleic acid, phosphatidylcholines (soya), polyethylene glycol, polyvinyl acetate phthalate, potassium acetate, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide. Bottles of 32 and 115.

Gelcaps

TYLENOL Rapid Release (500 mg Gelcaps): Each solid, capsule-shaped tablet, coated with red gelatin on one end, blue gelatin on the other end, a gray band between the two gelatin-coated ends, printed “TY” on one gelatin-coated end and “500” on the other gelatin-coated end, contains: acetaminophen 500 mg. Inactive ingredients: butylparaben, carboxymethylcellulose sodium, cellulose, corn starch, D&C yellow no. 10, edetate calcium disodium, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, methylparaben, polyethylene glycol, polysorbate 80, propylparaben, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide. Bottles of 20, 40 and 80.

Extended Release

TYLENOL Arthritis Pain 8Hour (650 mg Extended Release Tablet): Each elongated, bilayer yellow and white, extended release tablet, engraved “TYLENOL ART” on one side, contains: acetaminophen 650 mg (325 mg immediate release acetaminophen and 325 mg delayed release acetaminophen in a slow dissolving matrix). Inactive ingredients: carnauba wax, cellulose, corn starch, D&C yellow no. 10, FD & C yellow no. 6, hydroxyethyl cellulose, hypromellose, magnesium stearate, povidone, sodium starch glycolate, and triacetin.Bottles of 24, 50 and 100.

TYLENOL Muscle & Body (650 mg Extended Release Tablet): Each elongated, bilayer red and white, extended release tablet, engraved “TYLENOL ER” on one side, contains: acetaminophen 650 mg (325 mg immediate release acetaminophen and 325 mg delayed release acetaminophen in a slow dissolving matrix). Inactive ingredients: carnauba wax, cellulose, corn starch, FD&C red no. 40, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate and triacetin. Bottles of 16 and 72.

Children

Tablets

Children’s TYLENOL Chewables (160 mg) (Bubblegum): Round tablet, pink, one side debossed “TY” over “160”, the other side debossed with “HALF” over “HALF” and a center score line contains: acetaminophen 160 mg. Inactive ingredients: cellulose acetate, citric acid anhydrous, crospovidone, dextrose, D&C red no. 7 calcium lake, flavour, magnesium stearate, povidone, sucralose. Bottles of 20 tablets.

Children’s TYLENOL Chewables (160 mg) (Grape): Round tablet, purple, one side debossed “TY” over “160”, the other side debossed with “HALF” over “HALF” and a center score line, contains: acetaminophen 160 mg. Inactive ingredients: cellulose acetate, citric acid anhydrous, crospovidone, D&C red no. 7 calcium lake, D&C red no. 30 aluminum lake, dextrose, FD&C blue no. 1 aluminum lake, flavour, magnesium stearate, povidone, sucralose. Bottles of 20 tablets.

,u>Children’s TYLENOL Fastmelts 160 mg (Grape): Each round, white tablet with characteristic grape odour, debossed with “TYG 160” on one side and scored on the other side contains: acetaminophen 160 mg. Inactive ingredients: citric acid, copovidone, corn starch, crospovidone, ethylcellulose, flavour, lactose, magnesium stearate, mannitol, silicon dioxide, sorbitol, sucralose. Bottles of 20 tablets.

Suspension

Children’s TYLENOL (Suspension Liquid 160 mg/5 mL) (Banana Berry): Each 5 mL contains: acetaminophen 160 mg in a pink liquid vehicle with a strawberry-banana flavoured taste. Inactive ingredients: butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C red no. 40, flavour, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol and xanthan gum. Plastic bottles of 100 mL.

Children’s TYLENOL (Suspension Liquid 160 mg/5 mL)(Bubblegum): Each 5 mL contains: acetaminophen 160 mg in a dark pink liquid vehicle with a bubble gumflavoured taste. Inactive ingredients: butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, D&C red no. 33, FD&C red no. 40, flavour, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol and xanthan gum. Plastic bottles of 24 and 100 mL.

Children’s TYLENOL (Suspension Liquid 160 mg/5 mL) (Grape): Each 5 mL contains: acetaminophen 160 mg in a purple liquid vehicle with a grape-flavoured taste. Inactive ingredients: butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, D&C red no. 33, FD&C blue no. 1, flavour, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol and xanthan gum. Plastic bottles of 100 mL.

Children’s TYLENOL (Suspension Liquid 160 mg/5 mL) (Dye-Free Cherry): Each 5 mL contains: acetaminophen 160 mg in a pink liquid vehicle with a cherry-flavoured taste. Inactive ingredients: butylparaben, carboxymethylcellulose sodium, cellulose, flavours, glycerin, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, sucralose, sucrose and xanthan gum. Plastic bottles of 100 mL.

Children’s TYLENOL (Suspension Liquid 160 mg/5 mL) (Dye-Free Berry): Each 5 mL contains: acetaminophen 160 mg in a pink liquid vehicle with a berry-flavoured taste. Inactive ingredients: butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, flavours, glycerin, propylene glycol, propylparaben, purified water, sorbitol, sucralose powder, sucrose and xanthan gum. Plastic bottles of 100 mL.

Powder

Children’s TYLENOL Easy Dissolve (Acetaminophen Powder 160 mg each pack) (Wild Berry): Each stick pack contains: acetaminophen 160 mg as a white to off-white free flowing granular powder with a characteristic berry odour. Inactive ingredients: Citric acid, ethylcellulose, flavour, magnesium stearate, sodium bicarbonate, sucralose, xylitol. Carton containing 16 stick packs.

Suspension Drops

Infants' TYLENOL (Suspension Drops 80 mg/1 mL)(Cherry): Each mL contains: acetaminophen 80 mg in a red liquid vehicle with a cherry-flavoured taste. Inactive ingredients: butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C red no. 40, flavour, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol and xanthan gum. Plastic bottles of 15 mL and 24 mL with a calibrated syringe and push-in bottle applicator technology (SIMPLE MEASURE).

Infants' TYLENOL (Suspension Drops 80 mg/1 mL)(Dye-Free Grape): Each mL contains: acetaminophen 80 mg in a white to off-white liquid vehicle with a grapeflavoured taste. Inactive ingredients: butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, flavour, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol and xanthan gum. Plastic bottles of 15 mL, 24 mL and 24 mL(institutional use only) with a calibrated syringe and push-in bottle applicator technology (SIMPLE MEASURE).

All packages are safety sealed.

Marketing Informations Authorization Dates
Authorization holder:

McNeil Consumer Healthcare division of Johnson & Johnson Inc., 88 McNabb Street, Markham, Ontario, L3R 5L2

Submission control number:
Date of approval:

September 2, 2005

Date of revision:

June 15, 2021

Drugs

Drug Countries
TYLENOL Brazil, Canada, Mexico, South Africa

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