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Acetaminophen by Apotheca, Inc

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: Apotheca, Inc
NDC Code: 12634-111

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.

ACETAMINOPHEN TABLET 325MG

DRUG FACTS:
ACTIVE INGREDIENT

Acetaminophen 325mg

USES

Temporarily relieves minor aches and pains due to

  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • menstrual cramps

Temporarily reduces fever

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

do not take more then directed

adults and children 12 years and over

take 1 to 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

children 6 to under 12 years

take 1 tablet every 4 to 6 hours as needed. Do not take nore than 5 tablets in 24 hours

children under 6 years

consult a doctor. Do not use this adult regular strength product in children under 6 years of age, this will provide more than the recommended dose (overdose) acetominophen and may cause liver damage.

Tamper Evident: do not use if imprinted safety seal under cap is broken or missingStore between 20-25oC (68-77oF)Use by expiration date on packageTo report adverse drug events call 1-800-332-1088

WARNINGS

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

  • Adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • Child takes more than 5 doses in 24 hours
  • Taken with other drugs containing acetaminophen
  • Adult has 3 or more alcoholic drinks every day while using this product

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 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 sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

 Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. In the case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

  • do not take more than directed (see overdose warning).

 

Adults and children 12 years and over                     

Take 2 tablets every 4 to 6 while symptoms last.
Do not take more than 12 tablets in 24 hours.

Children 6 to under 12 years

Take 1 tablet every 4 to 6 while symptoms last.
Do not take more than 5 tablets in 24 hours.

Children under 6 years

Do not use adult regular strength products in childern under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

  • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
  • store between 20-25°C (68-77°F)
  • use by expiration date on package

 

INACTIVE INGREDIENTS

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

PRINCIPAL DISPLAY PANEL

NDC 12634-111-74

Acetaminophen

NON-ASPIRIN

Pain & Fever

Reliever

RejuviLife

24 TABLETS 325 MG

Distributed by:

RejuviLife, Phoenix, AZ

RejuviLife is a trademark of Apotheca, Inc

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12634-111(NDC:16103-353)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONES 
STARCH, CORN 
STARCH, POTATO 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint CodePH020
Contains    
Packaging
#Item CodePackage Description
1NDC:12634-111-7424 TABLET in 1 BOTTLE
2NDC:12634-111-6060 TABLET in 1 BOTTLE
3NDC:12634-111-01100 TABLET in 1 BOTTLE
4NDC:12634-111-101000 TABLET in 1 BOTTLE
5NDC:12634-111-911 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/01/1996
Labeler - Apotheca, Inc (051457844)
Establishment
NameAddressID/FEIOperations
Apotheca, Inc051457844relabel(12634-111)

 
Apotheca, Inc

← See all Acetaminophen brands

Medically reviewed on Jul 30, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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