Storage and handling
Other information store at 25° C (77° F) excursions permitted between 15°-30° C (59°-86° F) use by expiration date on package avoid excessive heat sodium free
TIME-GESIC
- Manufacturer
- Time-Cap Labs, Inc
- Effective date
- 2019-11-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-05-31 23:01:38
Label at a glance#
ProductTIME-GESIC
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 sections
Label contents#
Full prescribing information#
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver disease.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
OTC - STOP USE SECTION
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 appear; redness or swelling is present. These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or nursing, as with any drug, seek the advise of a health professional before using this product.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep this and all drugs out of reach of children.
DOSAGE & ADMINISTRATION SECTION
Directions
adults and children 12 years and over: take 1 to 2 tablets every six hours while symptoms last. Maximum daily dose is 9 tablets in 24 hours unless directed by a doctor.
children under 12 years: Do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.
STORAGE AND HANDLING SECTION
Other information
- store at 25° C (77° F) excursions permitted between 15°-30° C (59°-86° F)
- use by expiration date on package
- avoid excessive heat
- sodium free
INACTIVE INGREDIENT SECTION
colloidal silicon dioxide, crospovidone, fd&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid
INDICATIONS & USAGE SECTION
Uses: temporarily releives mnor aches and pains due to:
headache, backache, muscular aches, arthritis pain, colds, flu, fever, toothache, premenstrual cramps.
OTC - PURPOSE SECTION
Pain Reliever-fever reducer-antihistamine
WARNINGS SECTION
Warnings:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult or child 12 years and older takes more than 12 tablets in 24 hours, which is the maximum daily amount; taking with other durgs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product.
OTC - ACTIVE INGREDIENT SECTION
Each tablet contains:
acetaminophen 325 mg
diphenhydramine HCl 12.5 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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 |
|---|---|---|---|---|---|
| 49483-356-00 | 2023-01-30 | C162847 | 48780-1 | f386c649-cc37-0266-e053-dadaa90a7c1a | 356R APAP/DIPHEN hcl tABS 325/12.5 ORANGE FC CLEAR |
| 49483-356-09 | 2023-01-30 | C162847 | 48780-1 | f386c649-cc37-0266-e053-dadaa90a7c1a | 356R APAP/DIPHEN hcl tABS 325/12.5 ORANGE FC CLEAR |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49483-356-00 | TIME-GESIC | 100000 in 1 CARTON | TABLET, COATED | 100000 | 5 | |
| 49483-356-09 | TIME-GESIC | 90 in 1 BOTTLE, PLASTIC | TABLET, COATED | 90 | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 4 | |
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 4 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 4 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 4 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 4 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 4 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 4 |
Products#
Every source-derived product name is available through these pages.
- TIME-GESIC
- ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
- SILICON DIOXIDE
- CROSPOVIDONE
- FD&C YELLOW NO. 6
- HYPROMELLOSES
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POVIDONE
- STARCH, PREGELATINIZED CORN
- STEARIC ACID
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49483-356 | 49483-356-09, 49483-356-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSPOVIDONE | 68401960MK | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | FILM / SUBLINGUAL | 0.03 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | INSERT / VAGINAL | 54.21 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, DELAYED RELEASE / ORAL | 2 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED / ORAL | 0.03 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CREAM / TOPICAL | 0.1 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, COATED / ORAL | 3.17 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOAP / TOPICAL | 0.2 %w/w | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, FILM COATED / ORAL | 1 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, DELAYED RELEASE / ORAL | 105 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | SYSTEM / TOPICAL | 41 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | SOLUTION / OPHTHALMIC | 1.8 %w/v | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | ELIXIR / ORAL | 5.4 mg/5ml | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 350 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | POWDER, FOR SUSPENSION / ORAL | 35 mg/5ml | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / ORAL | 60.02 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE / ORAL | 45 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w |
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 |
|---|---|---|---|---|---|---|
| 97f18e17-9dda-8bf7-e053-2995a90ae67b | 889c5b6a-879e-425c-a25a-435766e9d601 | 2019-11-22 | Warnings | 97f18e17-9dda-8bf7-e053-2995a90ae67b 889c5b6a-879e-425c-a25a-435766e9d601 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.