ACETAMINOPHEN- acetaminophen tablet, film coated, extended release 
CHAIN DRUG MARKETING ASSOCIATION INC

----------

8 HOUR
Muscle Aches & Pain
Acetaminophen Extended-Release Tablets USP, 650 mg

Pain Reliever/Fever Reducer

For up to 8 hours relief of Minor Muscle Aches & Pain

Active ingredient

(in each caplet)
Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

Uses

■ temporarily relieves minor aches and pains due to:

■ muscular aches

■ backache

■ minor pain of arthritis

■ toothache

■ premenstrual and menstrual cramps

■ headache

■ the common cold

■ temporarily reduces fever

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

■ more than 6 caplets in 24 hours, which is the maximum daily amount

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Allergy alert

acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening

■ blisters

■ rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

■ if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

Keep out of reach of children

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

■ d o not take more than directed (see overdose warning)

adults and children 12 years of age and over

■ take 2 caplets every 8 hours with water

■ swallow whole; do not crush, chew, split or dissolve

■ do not take more than 6 caplets in 24 hours

■ do not use for more than 10 days unless directed by a doctor

children under 12 years

■ do not use

Other information

■ store between 20-25°C (68-77°F)

do not use if foil inner seal is broken or missing

Inactive ingredients

hydroxy ethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions or comments?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

50 count

ACETAMINOPHEN 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-413
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
Product Characteristics
Colorwhite (White to off white colored) Scoreno score
ShapeOVAL (Capsule shaped, biconvex intact film coated tablets) Size19mm
FlavorImprint Code G;650
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-413-5050 in 1 BOTTLE; Type 0: Not a Combination Product12/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21154412/31/2019
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Revised: 12/2020
Document Id: b7b5195b-a2aa-b60d-e053-2995a90abd17
Set id: 9f1c14af-8cfd-0a5d-e053-2a95a90ac940
Version: 2
Effective Time: 20201230
 
CHAIN DRUG MARKETING ASSOCIATION INC