Label: DIPHENHYDRAMINE- diphenhydramine hydrochloride capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 61010-4409-0, 61010-4409-1, 61010-4409-2 - Packager: Safetec of America, Inc.
- 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 January 27, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each capsule)
- 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
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?
- Principal Display Panel - 25 mg Pouch Label
- Principal Display Panel – 50 Pouches Carton Label
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Principal Display Panel – 100 Pouches Carton Label
Safetec®
of America, Inc.*Compare to the active ingredient in Benadryl®
NDC 61010-4409-2
Allergy Relief
Diphenhydramine HCl 25 mg – Antihistamine
- Itchy Watery Eyes
- Sneezing
- Runny Nose
PUSH TO OPEN
Dispense through opening
TAMPER EVIDENT UNIT DOSE POUCHES
DO NOT USE IF POUCH IS TORN OR DAMAGED
100 Pouches 2 Capsules per pouch
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE
diphenhydramine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-4409 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 benzyl alcohol (UNII: LKG8494WBH) butylparaben (UNII: 3QPI1U3FV8) D&C red NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color pink (PINK) , white ( WHITE) Score no score Shape OVAL (OVAL) Size 14mm Flavor Imprint Code AP;20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61010-4409-0 2 in 1 POUCH; Type 0: Not a Combination Product 12/30/2019 2 NDC:61010-4409-1 50 in 1 BOX 12/30/2019 2 NDC:61010-4409-0 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:61010-4409-2 100 in 1 BOX 12/30/2019 3 NDC:61010-4409-0 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 12/30/2019 Labeler - Safetec of America, Inc. (874965262)