Label: SLEEPAID (DIPHENHYDRAMINE HCL)- diphenhydramine hcl capsule, liquid filled
- NDC Code(s): 24689-154-01
- Packager: APNAR PHARMA LP
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 2, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Do not use
- for children under 12 years of age
- with any other products containing diphenhydramine, even one used on skin.
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 drinks
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
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SLEEPAID (DIPHENHYDRAMINE HCL)
diphenhydramine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24689-154 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SORBITAN (UNII: 6O92ICV9RU) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color blue Score no score Shape OVAL Size 13mm Flavor Imprint Code AD1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24689-154-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M010 05/04/2023 Labeler - APNAR PHARMA LP (079568229) Establishment Name Address ID/FEI Business Operations APNAR PHARMA LLP 118530917 manufacture(24689-154) , analysis(24689-154) , pack(24689-154)
