Label: ALLERGY RELIEF- diphenhydramine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 70005-001-02, 70005-001-25, 70005-001-50 - Packager: We Care Distributor Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 February 2, 2016
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 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 gland
- Directions
- Other Information
- Inactive Ingredients
- Questions or comments?
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Principal Display Panel
NDC: 70005-001-25
We Care
For Good Health
ALLERGY RELIEF
COMPARE TO THE ACTIVE INGREDIENT IN
Benadryl
CAPSULES
TO OPEN PUSH IN TAB AND PULL OUT
Diphenhydramine HCL, 25 mg
Antihistamine
Relieves:
- Sneezing
- Itchy Watery Eyes
- Runny Nose
- Itchy Throat
This product is not manufactured or distributed by Johnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division, owner of the registered trademark of Benadryl Capsules.
25 Pouches of 2 Coated Caplets
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70005-001 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL (UNII: 532B59J990) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) D&C RED NO. 27 (UNII: 2LRS185U6K) Product Characteristics Color pink Score no score Shape CAPSULE Size 11mm Flavor Imprint Code EL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70005-001-25 25 in 1 BOX 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:70005-001-50 50 in 1 BOX 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:70005-001-02 2 in 1 BOX 3 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/11/2016 Labeler - We Care Distributor Inc (079832998) Establishment Name Address ID/FEI Business Operations Elysium Pharmaceutical Ltd. 915664486 manufacture(70005-001)