Drug Facts: Active Ingredient
Acetaminophen 325mg
Acetaminophen
FDA Label NDC 12634-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apotheca, Inc for the product Acetaminophen (NDC 12634-111). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts: active ingredient, uses, indications & usage, warnings, dosage & administration, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
- 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
- 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
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
- do not take more than directed (see overdose warning).
- 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
Adults and children 12 years and over | Take 2 tablets every 4 to 6 while symptoms last. |
Children 6 to under 12 years | Take 1 tablet every 4 to 6 while symptoms last. |
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
* Please review the disclaimer below.
