Indications and uses
Temporary relief of occasional headaches and minor aches and pain with accompanying sleeplessness
ACETAINOPHEN AND DIPHENHYDRAMINE HCL TABLETS 500/25 mg
- Manufacturer
- HIMPRIT PHARMACHEM PVT LTD
- Effective date
- 2010-06-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:24:57
Label at a glance#
ProductACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections
Storage and handling
* Store at room temperature
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each Caplet) | Purpose |
|---|---|
| Acetaminophen 500 mg | Pain reliever/ fever reducer |
| Diphenhydramine HCL 25 mg | Sleep Aid |
Uses
Temporary relief of occasional headaches and minor aches and pain with accompanying sleeplessness
Warnings
Alcohol Warnings
If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.
Do not use
- with any other product containing acetaminophen
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
ASK a doctor or pharmacists before use if you are taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
- do not exceed recommended dosage
- avoid alcoholic beverages
- marked drowsiness may occur
- do not drive a motor vehicle or operate machinery
OTC - STOP USE SECTION
Stop use and ask a doctor if
- sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of accidental overdose get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Direction
- use as directed
- adults and children 12 years and over : take 2 caplets at bedtime or as directed by a doctor
- Children under 12 years : do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.
Other information
- Store at room temperature
Inactive ingredients
croscarmellose sodium, hypromellose, polythlene glycol,sodium metabisulfate, stearic acid,, sodium starch glycolate,collodial silicon dioxide, FD & C blue # 1
PRINCIPAL DISPLAY PANEL 500/25 mg Shipper Label
ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLETS
Each Film coated Tablet Contains:
ACETAMEINOPHEN 500 mg
DIPHENHYDRAMINE HCL 25 mg
Lot No :
MFG. DATE :
Exp. Date :
Jar No. :
Quantity : 31000 Tablets
NDC. No : 65437-041-31
WARNING :
KEEP OUT OF THE REACH OF CHILDREN
STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER
MANUFACTURED BY:
MANUFACTURED CODE No Guj/Drugs/G/1362
LABELER CODE # 14803
MANUFACTURED FOR:
HIMPRIT PHARMACHEM PVT. LTD
"LAKULISH", R.V.DESAI ROAD,
NEXT TO NAVAPURA POLICE STATION
BARODA, INDIA – 390 001
CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65437-041-31 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3010-f424-e053-dadaa90a57ce | ACETAINOPHEN AND DIPHENHYDRAMINE HCL TABLETS 500/25 mg |
| 65437-041-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3010-f424-e053-dadaa90a57ce | ACETAINOPHEN AND DIPHENHYDRAMINE HCL TABLETS 500/25 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65437-041-31 | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 31000 in 1 BAG | TABLET, FILM COATED | 31000 | 1 | |
| 65437-041-31 | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 1 in 1 DRUM | TABLET, FILM COATED | 1 | 1 | |
| 65437-041-50 | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 1 in 1 DRUM | TABLET, FILM COATED | 1 | 1 | |
| 65437-041-50 | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 50000 in 1 BAG | TABLET, FILM COATED | 50000 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- SODIUM METABISULFITE
- CELLULOSE, MICROCRYSTALLINE
- CROSCARMELLOSE SODIUM
- STEARIC ACID
- POLYETHYLENE GLYCOL
- FD&C BLUE NO. 1
- TITANIUM DIOXIDE
- WATER
- SILICON DIOXIDE
- FD&C BLUE NO. 2
- HYPROMELLOSE
- TALC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65437-041 | 65437-041-31, 65437-041-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| SODIUM METABISULFITE | 4VON5FNS3C | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POLYETHYLENE GLYCOL | 3WJQ0SDW1A | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| WATER | 059QF0KO0R | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| HYPROMELLOSE | 3NXW29V3WO | IACT |
| TALC | 7SEV7J4R1U | IACT |
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 |
|---|---|---|---|---|---|---|
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / BUCCAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, COATED PELLETS / ORAL | 198 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 144 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | SOAP / TOPICAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | PELLET / ORAL | 69 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, DELAYED RELEASE / ORAL | 420 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, ORALLY DISINTEGRATING / ORAL | 184 mg | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION, SOLUTION / INFILTRATION | 0.05 %w/v | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION / INTRACARDIAC | 0.09 %w/v | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | TABLET / ORAL | 8 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | SOLUTION / RESPIRATORY (INHALATION) | 0.3 %w/w | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE / ORAL | 150 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, CHEWABLE / ORAL | 216 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | TABLET, EXTENDED RELEASE / ORAL | 1472 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | CAPSULE, DELAYED RELEASE / ORAL | 0.22 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION / SUBCUTANEOUS | 43 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | SUSPENSION / TOPICAL | 0.32 %w/v | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | SUSPENSION / ORAL | 40 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, EXTENDED RELEASE / ORAL | 300 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION / INTRA-ARTICULAR | 0.2 %w/v | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE / ORAL | 729 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, EXTENDED RELEASE / ORAL | 53 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 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 |
|---|---|---|---|---|---|---|
| 13d391cd-6737-4d5d-a811-4cd602ec0013 | 6a2c1efb-d91b-48d2-b623-aa941e2c6f0e | 2010-06-15 | Warnings | 13d391cd-6737-4d5d-a811-4cd602ec0013 6a2c1efb-d91b-48d2-b623-aa941e2c6f0e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.