FDA Label for Extra Strength Pain Relief
View Indications, Usage & Precautions
Extra Strength Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Acetaminophen 500 mg
Purpose
Pain Reliever/Fever Reducer
Uses
- temporarily relieves minor aches and pains due to:
- - headache
- - muscular aches
- - backache
- - arthritis
- - the common cold
- - toothache
- - menstrual cramps
- temporarily reduces fever
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 gelcaps in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 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.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptom 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 signs 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 case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
- Do not take more than directed (see overdose warnings)
Adults and children 12 years and over - Take 2 gelcaps every 4-6 hours, as needed.
- Do not take more than 8 gelcaps in 24 hours
Children under 12 years Do not use
Other Information
- TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
- store at controlled room temperature 20⁰C-25⁰C (68⁰F-77⁰F)
- avoid high humidity
Inactive Ingredients
croscarmellose sodium, D&C Red #33, FD&C Blue #1, FD&C Red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide, PEG, povidone, propylene glycol, shellac glaze, starch, stearic acid, titanium dioxide.
Package Label
NDC 68016-029-47
Compare to active ingredient in Extra Strength Tylenol Rapid Release Gels*
Extra Strength
PAIN RELIEF
ACETAMINOPHEN
Rapid Release
Pain Reliever/ Fever Reducer
Gelcaps
400 Gelcaps
500 mg each
* Please review the disclaimer below.