Tension Headache Relief by FRED'S, INC.
Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, CAFFEINE 65mg
Labeler: FRED'S, INC.
NDC Code: 55315-428
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 500 mg
(formulated with 65 mg caffeine)
- temporarily relieves minor aches and pains due to:
- muscular aches
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.
- 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
taking the blood thinning drug warfarin.
- pain gets worse or lasts for more than 10 days
- new symptoms occur
- fever gets worse or lasts for more than 3 days
- painful area is red or swollen
These could be signs of a serious condition.
ask a health professional before use.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
do not use more than directed
- adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 6 caplets in 24 hours.
- children under 12 years: ask a doctor
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
corn starch, crospovidone, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide
Compare to the active ingredients in:
Excedrin® Tension Headache*
Acetaminophen 500 mg, Caffeine 65 mg
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by GSK group of companies, owner of the registered trademark Excedrin® Tension Headache.
DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 382118
|TENSION HEADACHE RELIEF
acetaminophen, caffeine tablet, film coated
|Labeler - FRED'S, INC. (005866116)|
|LNK International, Inc.||038154464||PACK(55315-428)|
|LNK International, Inc.||832867894||MANUFACTURE(55315-428)|
|LNK International, Inc.||967626305||PACK(55315-428)|
|LNK International, Inc.||868734088||PACK(55315-428)|
Medically reviewed on Nov 8, 2017