Indications and uses
for temporary relief of minor aches and pains due to: headache backache muscular aches arthritis pain colds flu fever toothache premenstrual and menstrual cramps Temporarily relieves runny nose sneezing itchy nose and throat
Percogesic
- Manufacturer
- Medtech Products Inc.
- Effective date
- 2024-02-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:09:30
Label at a glance#
ProductPercogesic Extra Strength
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE
Label structure12 sections
Dosage and administration
Adults and children 12 years of age and older: take 2 caplets every 6 hours. Maximum daily dose is 6 tablets. Children under 12 years of age: ask a doctor.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredient (in each caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Active Ingredient (in each caplet)
Diphenhydramine HCl 12.5 mg
Purpose
Antihistamine
Uses:
for temporary relief of minor aches and pains due to:
- headache
- backache
- muscular aches
- arthritis pain
- colds
- flu
- fever
- toothache
- premenstrual and menstrual cramps
Temporarily relieves
- runny nose
- sneezing
- itchy nose and throat
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 tablets 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.
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash.
If a skin reaction occurs, stop use and seek medical help right away.
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.
- with any other product containing diphenhydramine, even one used on skin
- If you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
Ask a doctor or pharmacist before use if your are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- marked drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may cause drowsiness
- may cause excitability, especially in children
- be careful driving a motor vehicle or operating machinery.
Stop use and ask a doctor if
- pain persists for more than 10 days
- fever persists for more than 3 days (unless directed by a doctor)
- condition worsens or new symptoms occur
- redness or swelling is present.
These may be signs of a serious condition.
If you are pregnant or breast-feeding,
ask a health professional before use.
Keep out of the reach of children.
Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of 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 exceed recommended dosage.
Directions
Adults and children 12 years of age and older: take 2 caplets every 6 hours. Maximum daily dose is 6 tablets. Children under 12 years of age: ask a doctor.
Other information
- store at 15°-30°C (59°-86°F)
- avoid excessive heat
Inactive ingredients
croscarmellose sodium, FD&C yellow no. 6 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyvinylpyrrolidone, silica, sodium carboxymethyl starch, starch, stearic acid, talc, titanium dioxide, triacetin
Questions?
1-800-443-4908
PRINCIPAL DISPLAY PANEL
EXTRA STRENGTH
Percogesic®
Acetaminophen/
Diphenhydramine
Fever Reducer/ Antihistamine
40 COATED CAPLETS
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63029-054-40 | PercogesicExtra Strength | 1 in 1 CARTON | CAPSULE, COATED | 1 | 1 | |
| 63029-054-40 | PercogesicExtra Strength | 40 in 1 BOTTLE, PLASTIC | CAPSULE, COATED | 40 | 1 | |
| 63029-054-60 | PercogesicExtra Strength | 1 in 1 CARTON | CAPSULE, COATED | 1 | 1 | |
| 63029-054-60 | PercogesicExtra Strength | 60 in 1 BOTTLE, PLASTIC | CAPSULE, COATED | 60 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Percogesic Extra Strength
- acetaminophen and diphenhydramine
- ACETAMINOPHEN
- DIPHENHYDRAMINE
- CROSCARMELLOSE SODIUM
- FD&C YELLOW NO. 6
- HYPROMELLOSES
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- MINERAL OIL
- SILICON DIOXIDE
- SODIUM STARCH GLYCOLATE TYPE A
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- TRIACETIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63029-054 | 63029-054-60, 63029-054-40 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE | 8GTS82S83M | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
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 |
|---|---|---|---|---|---|---|
| Percogesic Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE | Medtech Products Inc. | 2c5f1140-fb83-42c9-b0b1-5e2bd69340bb | 2024-02-01 | Warnings | 63029-054-60 63029-054-40 63029-054 63029005460 63029005440 dd068345-eb74-40b1-80b5-ef9df6fde1cd 2c5f1140-fb83-42c9-b0b1-5e2bd69340bb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.