Label: ONLY FOR ALLERGY- diphenhydramine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 73006-148-95 - Packager: O4 Global Trading Usa, Llc
- 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 November 18, 2020
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
- Active ingredient (in each caplet)
- Purpose
- Uses:
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Warnings:
Do not use
• to make a child sleepy
• with any other product 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 glandAsk a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
When using this product
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children.If pregnant or breast-feeding,
ask a health professional before use. - Directions:
- Other Information:
- Inactive Ingredients:
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
ONLY FOR ALLERGY
diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73006-148 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape OVAL (CAPLET) Size 11mm Flavor Imprint Code DP Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73006-148-95 1 in 1 CARTON 11/15/2020 1 25 in 1 BOTTLE, PLASTIC; 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 11/15/2020 Labeler - O4 Global Trading Usa, Llc (081226861)