ACETAMIOPHEN- acetaminophen tablet, extended release 
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

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Acetaminophen ER 650 mg

Drug Facts

Active Ingredients (In each caplet)

Active ingredient (in each caplet)
                                                          Purpose
Acetaminophen 650 mg
                              Pain reliever/fever reducer

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 650mg ....................... Pain reliever/fever reducer.

Uses

Warnings

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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

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

Do not use

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

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 Poision Control of 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 of symptoms.

Directions

Adults and children 12 years and over:

Children under 12 years:

Other information

Inactive ingredients

hydroxyethyl cellulose, maize starch, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, FD&C yellow no. 6 aluminum lake and FD&C yellow no. 10 aluminum lake.

Questions or comments?

Call: 1.866.901.DRUG (3784) (toll-free)

Manufactured for

Heritage Pharmaceuticals Inc.,

Eatontown, NJ 07724

1.866.901.DRUG (3784)

Made in India

Rev.08/16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton

carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 24 Caplets Label

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 100 Caplets label

100 caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 20000 Tablets

20000 tablets
ACETAMIOPHEN 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23155-202
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 (140 CPS AT 5%) (UNII: 8136Y38GY5)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITE (caplet) Scoreno score
ShapeCAPSULE (yellow layer and white coloured plain layer) Size19mm
FlavorImprint Code 511
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:23155-202-641 in 1 CARTON06/01/2018
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:23155-202-651 in 1 CARTON06/01/2018
2750 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:23155-202-011 in 1 CARTON06/01/2018
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:23155-202-1820000 in 1 CONTAINER; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20703506/01/2018
Labeler - Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (780779901)
Registrant - Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. (189630168)
Establishment
NameAddressID/FEIBusiness Operations
Micro Labs Limited915793658MANUFACTURE(23155-202)

Revised: 6/2023
Document Id: e8b62009-b9ec-4303-86b4-e4abdc210a2c
Set id: 63cc5d4a-91bc-45cc-9736-089e39ae344c
Version: 10
Effective Time: 20230623
 
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.