Dosage and administration
Adults and children 12 years and older: take 2 tablets at bedtime if needed, or as directed by your doctor.
Sominex
- Manufacturer
- Navajo Manufacturing Company Inc.
- Effective date
- 2019-11-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:58:01
Label at a glance#
ProductSominex
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Diphenhydramine HCI 25 mg
Purpose
Nighttime sleep-aid
Use
helps reduce difficulty falling asleep
Warnings
Do not use
• in children under 12 years of age • with any other product containing diphenhydramine, even one used on skin
• with other antihistamines
Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
When using this product
• avoid alcoholic beverages • be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
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.
Directions
Adults and children 12 years and older: take 2 tablets at bedtime if needed, or as directed by your doctor.
Other information
• each tablet contains: calcium 10mg
• store at room temperature 20°-25°C (68°-77°F)
Inactive ingredients
croscarmellose sodium, dicalcium phosphate, FD&C blue no.1 lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, triacetin.
Questions?
1-866-255-5202 weekdays
Package Labeling:
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67751-169-01 | 2023-03-16 | C162847 | 48780-1 | f386c64a-1739-0266-e053-dadaa90a7c1a | Sominex |
| 67751-169-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1739-0266-e053-dadaa90a7c1a | Sominex |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63029-555-01 | EA - Each | 63029-555 | 3aeb6f90-c8e3-4b0f-9e00-6dec7af3be24 | 1 | 2022-06-06 |
| 63029-555-16 | EA - Each | 63029-555 | c731d24c-fdf3-4667-86aa-5f294b77bb1e | 1 | 2022-06-06 |
| 63029-555-32 | EA - Each | 63029-555 | b0cff55e-5966-46fc-90af-46a96a604ba5 | 1 | 2022-06-06 |
Products#
Every source-derived product name is available through these pages.
- Sominex
- DIPHENHYDRAMINE HYDROCHLORIDE
- CROSCARMELLOSE SODIUM
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- FD&C BLUE NO. 1
- HYPROMELLOSE, UNSPECIFIED
- LACTOSE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- MINERAL OIL
- SILICON DIOXIDE
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- TRIACETIN
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67751-169 | 67751-169-01 |
| 63029-555 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| f70bb1d0-7562-027d-e053-6294a90af08d | 9d2cbdff-2231-4d80-8481-22bcb8385506 | 2023-03-16 | Warnings | 9d2cbdff-2231-4d80-8481-22bcb8385506 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.