Indications and uses
temporarily relieves minor aches and pains due to: - headache - muscular aches - backache - arthritis - the common cold - toothache - menstrual cramps temporarily reduces fever
Extra Strength Pain Relief
- Manufacturer
- Chain Drug Consortium, LLC | Geri-Care Pharmaceutical Corp
- Effective date
- 2023-10-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:23:49
Label at a glance#
ProductExtra Strength Pain Relief
Active ingredientACETAMINOPHEN
Label structure7 sections
Dosage and administration
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
Storage and handling
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 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.
Label contents#
Full prescribing information#
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
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.
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 more than 10 days
- fever gets worse or lasts more than 3 days
- new symptom occur
- redness or swelling is present
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 SECTION
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
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68016-029-14 | EA - Each | 68016-029 | dd8b1c4a-a808-449b-8e4c-84408c969413 | 1 | 2015-02-02 |
| 68016-029-20 | EA - Each | 68016-029 | a83ed7da-a56a-4832-8c0e-ee80b1ababcb | 1 | 2015-02-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Extra Strength Pain Relief
- Acetaminophen
- CROSCARMELLOSE SODIUM
- D&C RED NO. 33
- FD&C BLUE NO. 1
- GELATIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- PROPYLENE GLYCOL
- STARCH, CORN
- STEARIC ACID
- TITANIUM DIOXIDE
- FD&C RED NO. 40
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- HYPROMELLOSES
- FERRIC OXIDE RED
- SHELLAC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68016-029 | 68016-029-20, 68016-029-14, 68016-029-47 |
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 |
|---|---|---|---|---|---|---|
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED PELLETS / ORAL | 65 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CAPSULE / ORAL | 1 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, EXTENDED RELEASE / ORAL | 194 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER, FOR SUSPENSION / ORAL | NA | ||
| SHELLAC | SHELLAC | 46N107B71O | SUSPENSION / ORAL | 3 mg/1ml | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | JELLY / TOPICAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, EXTENDED RELEASE / ORAL | 392 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, FILM COATED / ORAL | 131.67 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CONCENTRATE / ORAL | 0.04 mg/1ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SOLUTION / INTRAVENOUS | 34.8 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, EXTENDED RELEASE / ORAL | 239 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE / ORAL | 150 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE, EXTENDED RELEASE / ORAL | 75.01 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / SUBLINGUAL | 36 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET, COATED / ORAL | 30 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CONCENTRATE / ORAL | 0.02 mg/1ml | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | GRANULE / ORAL | 13 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / INTRAVENOUS | 50.33 %w/v | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | INSERT / VAGINAL | 54.21 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SOLUTION / OPHTHALMIC | 1.8 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, SUGAR COATED / ORAL | NA | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | TABLET, FILM COATED / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / ORAL | 46 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRAMUSCULAR | 16 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | POWDER, FOR SUSPENSION / ORAL | 200 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, CHEWABLE / ORAL | 10 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 127 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TROCHE / ORAL | 50 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | GRANULE, FOR SUSPENSION / ORAL | 194 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 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 |
|---|---|---|---|---|---|---|
| 27fdfee0-44d8-1f36-e063-6394a90a68a4 | 05e11584-1876-0207-e054-00144ff88e88 | 2024-11-28 | Warnings | 05e11584-1876-0207-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.