Acetaminophen by Apotheca, Inc ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Apotheca, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12634-111(NDC:16103-353)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONES (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STARCH, POTATO (UNII: 8I089SAH3T)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	PH020
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12634-111-74	24 in 1 BOTTLE
2	NDC: 12634-111-60	60 in 1 BOTTLE
3	NDC: 12634-111-01	100 in 1 BOTTLE
4	NDC: 12634-111-10	1000 in 1 BOTTLE
5	NDC: 12634-111-91	1 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/01/1996

Labeler - Apotheca, Inc (051457844)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca, Inc		051457844	relabel(12634-111)