Label: SOMINEX- diphenhydramine hydrochloride tablet, film coated
- NDC Code(s): 63029-554-01, 63029-554-16, 63029-554-32
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated May 18, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
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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
When using this product
- avoid alcoholic beverages
- be careful when driving a motor vehicle or operating machinery
- in children under 12 years of age
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOMINEX
diphenhydramine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-554 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) LIGHT MINERAL OIL (UNII: N6K5787QVP) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color BLUE (Light Blue) Score no score Shape ROUND Size 10mm Flavor Imprint Code S;S Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-554-32 4 in 1 BOX 06/01/2012 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63029-554-16 2 in 1 BOX 06/01/2012 2 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:63029-554-01 9 in 1 BOX 06/01/2012 3 8 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part338 06/01/2012 Labeler - Medtech Products Inc. (122715688)