ACETAMINOPHEN- acetaminophen tablet, film coated, extended release 
Family Dollar Services, Inc.

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Acetaminophen

Drug Facts

Active ingredient (in each caplet)

Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
minor pain of arthritis
muscular aches
backache
premenstrual and menstrual cramps
the common cold
headache
toothache
temporarily reduces fever

Warnings

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.

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

do not take more than directed (see overdose warning)

adults

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

under 18 years of age

ask a doctor

Other information

store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
see end panel for batch number and expiration date
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive ingredients

crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

Questions?

call 1-800-406-7984

DISTRIBUTED BY: MIDWOOD BRANDS, LLC
500 Volvo Parkway, Chesapeake, VA 23320 USA

PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton

FAMILY
wellness™

COMPARE TO
TYLENOL® ARTHRITIS PAIN*

EASY
TO OPEN
BOTTLE

Use only as directed.
NDC 55319-333-01

ARTHRITIS
Pain Relief
Acetaminophen Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

Lasts up to
8 Hours

DO NOT USE WITH OTHER
MEDICINES CONTAINING
ACETAMINOPHEN

ACTUAL SIZE

THIS PACKAGE FOR
HOUSEHOLDS WITHOUT
YOUNG CHILDREN

100% SATISFACTION
OR YOUR MONEY BACK
GUARANTEED

100 CAPLETS* (*Capsule-Shaped Tablets)

PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton
ACETAMINOPHEN 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-333
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (Capsule Shaped) Size19mm
FlavorImprint Code cor116
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-333-2324 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2017
2NDC:55319-333-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620009/01/2017
Labeler - Family Dollar Services, Inc. (024472631)
Registrant - Ohm Laboratories Inc. (051565745)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745MANUFACTURE(55319-333)

Revised: 7/2020
Document Id: 9f6c1828-d7a7-489c-91c4-fd6f4faf2dc8
Set id: c65ef88a-ec37-4d61-8420-17f4807ac93a
Version: 8
Effective Time: 20200706
 
Family Dollar Services, Inc.