Label: FIRSTCARE CHILDRENS ALLERGY RELIEF- diphenhydramine hcl bar, chewable
- NDC Code(s): 71594-705-08
- Packager: USpharma Ltd
- 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 December 16, 2020
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- Official Label (Printer Friendly)
- Active ingredient (in each soft chew)
- Purpose
- Uses
-
Warnings
Do not use
- To make 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
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 times in 24 hours
- Instruct child to chew each soft chew thoroughly before swallowing
- find right dose on chart below
Age (yr)
Dose (soft chew)
Children under 2 years
Do not use
Children 2 to 5 years
Do not use unless directed by a doctor
Children 6 to 11 years
1 to 2 soft chews (12.5 mg to 25 mg)
Adults and children 12 years and over
2 to 4 soft chews (25 mg to 50 mg)
- SPL UNCLASSIFIED SECTION
- Inactive ingredients:
- SPL UNCLASSIFIED SECTION
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
FIRSTCARE CHILDRENS ALLERGY RELIEF
diphenhydramine hcl bar, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71594-705 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg Inactive Ingredients Ingredient Name Strength TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SODIUM CHLORIDE (UNII: 451W47IQ8X) SUCRALOSE (UNII: 96K6UQ3ZD4) NEOTAME (UNII: VJ597D52EX) CORN SYRUP (UNII: 9G5L16BK6N) CARRAGEENAN (UNII: 5C69YCD2YJ) MALTITOL (UNII: D65DG142WK) HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCROSE (UNII: C151H8M554) MINERAL OIL (UNII: T5L8T28FGP) STARCH, CORN (UNII: O8232NY3SJ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color yellow (Light yellow to golden brown) Score no score Shape RECTANGLE Size 18mm Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71594-705-08 20 in 1 BOTTLE; Type 0: Not a Combination Product 05/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/21/2020 Labeler - USpharma Ltd (080664601) Registrant - USpharma Ltd (080664601) Establishment Name Address ID/FEI Business Operations USpharma Ltd 080664601 manufacture(71594-705) , pack(71594-705)