ACETAMINOPHEN- acetaminophen tablet 
Apotheca, 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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ACETAMINOPHEN TABLET 325MG

DRUG FACTS:
ACTIVE INGREDIENT

Acetaminophen 325mg

USES

Temporarily relieves minor aches and pains due to

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

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 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

 

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

 

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

image description

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12634-111(NDC:16103-353)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONES (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STARCH, POTATO (UNII: 8I089SAH3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code PH020
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12634-111-7424 in 1 BOTTLE
2NDC:12634-111-6060 in 1 BOTTLE
3NDC:12634-111-01100 in 1 BOTTLE
4NDC:12634-111-101000 in 1 BOTTLE
5NDC:12634-111-911 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/FEIBusiness Operations
Apotheca, Inc051457844relabel(12634-111)

Revised: 7/2013
Document Id: 131d4041-7086-411f-ab71-37c091d1377a
Set id: b8e87809-405f-4e2a-9b42-3ca10c38da13
Version: 1
Effective Time: 20130729
 
Apotheca, Inc