Label: DIPHENHYDRAMINE HCL capsule
- NDC Code(s): 55154-0683-0
- Packager: Cardinal Health 107, LLC
- This is a repackaged label.
- Source NDC Code(s): 0904-5306
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each banded capsule)
- Purpose
- Keep Out of Reach of Children
-
Uses-
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold- sneezing - runny nose - itchy, watery eyes - itchy throat and nose.
When using this product:
- •
- Marked drowsiness may occur
- •
- avoid alcoholic drinks
- •
- alcohol, sedatives, and tranquilizers may increase drowsiness
- •
- use caution when driving a motor vehicle or operating machinery
- •
- excitability may occur, especially in children
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Warnings
Do not use – to make a child sleepy – with any other products containing diphenhydramine, including one applied topically
Ask a doctor before use if you have –glaucoma -a breathing problem such as emphysema or chronic bronchitis –difficulty in urination due to enlargement of the prostate gland
This unit dose package is not child resistant and is intended for institutional use only. Keep out of the reach of children.
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away.
DO NOT USE IF BLISTER UNIT IS BROKEN
- Directions-Take every 4 to 6 hours – do not take more than 6 doses in 24 hours
- Inactive ingredients
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Storage
Store at 20-25 C (68-77 F); excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature].
-protect from moisture
-contains lactose
Questions or comments? (800) 616-2471
Distributed by
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
MFGD By CPC, NY 11788
Distributed By:
Cardinal Health
Dublin, OH 43017
L36150280122
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-0683(NDC:0904-5306) 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 D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color PINK Score no score Shape CAPSULE Size 14mm Flavor Imprint Code CPC;835 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-0683-0 10 in 1 BAG 06/03/2011 07/31/2025 1 1 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 Drug M012 06/03/2011 07/31/2025 Labeler - Cardinal Health 107, LLC (118546603)
