ACETAMINOPHEN PAIN RELIEVER,FEVER REDUCER- acetaminophen tablet 
NuCare Pharmaceuticals,Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purposes

Pain reliever/fever reducer

Warnings

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

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

  • with any other drug containing acetaminophen (prescription or non prescription). 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 the user has

liver disease.

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

Pain gets worse or lasts more than 10 days in adults and children

Pain gets worse or lasts more than 5 days in children under 12 years

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:

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Uses

for the temporary relief of minor aches and pains due to:

Temporarily reduces fever.


Directions

Do not take more than directed

AGEDOSE
Adults and Children 12 years and over
  • Take 2 tablets every 4 to 6 hours while symptoms last
  • Do not take more than 12 tablets in 24 hours
Children 6 - 11 years
  • Take 1 tablet every 4 to 6 hours while symptoms last
  •  Do not take more than 5 tablets in 24 hours
Children under 6 yearsDo not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information


Inactive ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Questions?

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

Principal Display Panel

PDP

ACETAMINOPHEN  PAIN RELIEVER,FEVER REDUCER
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4118(NDC:51645-703)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (round) Scoreno score
ShapeROUND (flat faced beveled edge) Size10mm
FlavorImprint Code GPI;A325
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-4118-220 in 1 BOTTLE; Type 0: Not a Combination Product10/13/2017
2NDC:68071-4118-525 in 1 BOTTLE; Type 0: Not a Combination Product10/13/2017
3NDC:68071-4118-330 in 1 BOTTLE; Type 0: Not a Combination Product10/13/2017
4NDC:68071-4118-440 in 1 BOTTLE; Type 0: Not a Combination Product10/13/2017
5NDC:68071-4118-660 in 1 BOTTLE; Type 0: Not a Combination Product10/13/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/27/2006
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300repack(68071-4118)

Revised: 1/2022
Document Id: d6070f38-515c-049e-e053-2a95a90aade6
Set id: 5b6f4839-1f2b-94b2-e053-2a91aa0a85e0
Version: 4
Effective Time: 20220120
 
NuCare Pharmaceuticals,Inc.