Indications and uses
temporarily relieves minor aches and pains due to: headache muscular aches
Tension Headache Relief
- Manufacturer
- FRED'S, INC. | LNK International, Inc.
- Effective date
- 2020-06-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:26:30
Label at a glance#
ProductTension Headache Relief
Active ingredientACETAMINOPHEN, CAFFEINE
Label structure9 sections
Dosage and administration
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
Storage and handling
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number
Contacts and useful links#
Websitewww.fredsinc.com
www.fredsinc.com
www.fredsinc.comLabel contents#
Full prescribing information#
Active ingredients (in each caplet)
Acetaminophen 500 mg
(formulated with 65 mg caffeine)
Purpose
Pain reliever
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
Warnings
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:
- blisters
- rash
- 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.
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
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 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.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
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.
Directions
- 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
Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
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
Questions or comments?
1-800-426-9391
Principal Display Panel
Fred's
Pharmacy
NDC 55315-428-08
Compare to the active ingredients in:
Excedrin® Tension Headache*
TENSION
HEADACHE RELIEF
Acetaminophen 500 mg, Caffeine 65 mg
Pain Reliever
Aspirin Free
24 CAPLETS
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.
50844 REV0417A42808
DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118www.fredsinc.com
100% satisfaction
guaranteed
Questions or comments: 1-855-331-FRED (3733)
Products#
Every source-derived product name is available through these pages.
- Tension Headache Relief
- Acetaminophen, Caffeine
- ACETAMINOPHEN
- CAFFEINE
- STARCH, CORN
- CROSPOVIDONE
- D&C RED NO. 27 ALUMINUM LAKE
- FD&C BLUE NO. 2--ALUMINUM LAKE
- FD&C YELLOW NO. 6
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- POLYVINYL ALCOHOL, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55315-428 | 55315-428-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 045aee17-b3df-4a98-af9d-2cf56b91d02d | 5b765168-eca1-4bc0-8bfa-3dc53283d600 | 2020-06-11 | Warnings | 045aee17-b3df-4a98-af9d-2cf56b91d02d 5b765168-eca1-4bc0-8bfa-3dc53283d600 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.