Indications and uses
temporarily relieves minor aches and pains due to: headache muscular aches
Tension Headache Relief
- Manufacturer
- Chain Drug Consortium | LNK International, Inc.
- Effective date
- 2021-08-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:38:11
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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Contacts and useful links#
Label 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
- new symptoms occur
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- 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
Premier
Value®
*COMPARE TO THE ACTIVE INGREDIENTS IN EXCEDRIN® TENSION HEADACHE
Tension
Headache Relief
Acetaminophen 500 mg / Caffeine 65 mg
PAIN RELIEVER
Aspirin free
100 Caplets
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
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 REV0417A42812
Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68016-694-10 | EA - Each | 68016-694 | 759490e2-6dac-4931-8abd-15c2ee8fd72d | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| CAFFEINE | ACTIVE INGREDIENT | 3G6A5W338E | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | 1 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
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
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68016-694 | 68016-694-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION, EXTENDED RELEASE / ORAL | 46 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | CAPSULE, EXTENDED RELEASE / ORAL | 4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER / ORAL | 20 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, DELAYED RELEASE / ORAL | 0.2 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET / ORAL | 25 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET / BUCCAL | 0.01 mg | ||
| TALC | TALC | 7SEV7J4R1U | DROPS / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LOTION / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, EXTENDED RELEASE / ORAL | 5119 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 17 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / RECTAL | 32.4 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SUSPENSION/ DROPS / OPHTHALMIC | 1.4 %w/v | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | DROPS / ORAL | 0.2 mg/1ml | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, EXTENDED RELEASE / ORAL | 1.43 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / BUCCAL | 1 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | IMPLANT / INTRAVITREAL | 0.12 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SUSPENSION / AURICULAR (OTIC) | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| TALC | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | POWDER, FOR SUSPENSION / ORAL | 735 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LIQUID / ORAL | 0.2 mg/1ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, FILM COATED / ORAL | 1 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | CAPSULE / ORAL | 1.67 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, ORALLY DISINTEGRATING / ORAL | 12 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED PELLETS / ORAL | NA | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, COATED / ORAL | 24.12 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, COATED / ORAL | 49.2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg |
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 |
|---|---|---|---|---|---|---|
| 74977475-2743-426d-a12a-4eb29057c2b3 | 1bbf3733-930f-4670-841f-f0690bf4fba4 | 2022-08-10 | Warnings | 1bbf3733-930f-4670-841f-f0690bf4fba4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.