Label: CVS HEALTH CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride liquid
- NDC Code(s): 59779-793-10
- Packager: CVS Pharmacy,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 December 30, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL blister)
- Purpose
- Uses
-
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 the child has
- •
- a breathing problem such as chronic bronchitis
- •
- glaucoma
-
Directions
- •
- find right dose on chart below
- •
- break tab on blister
- •
- pour liquid directly into mouth or into teaspoon
- •
- be careful of blister edges to prevent cuts on skin
- •
- take every 4 to 6 hours
- •
- do not take more than 6 doses in 24 hours
Age (yr)
Dose (tsp)
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 single-dose blisters(12.5mg to 25mg)
- Other information
- Inactive ingredients
-
PRINCIPAL DISPLAY PANEL
CVS Health ™
Compare to the active ingredient in Children's
Benadryl® *Dye-Free Liquid
Children’s Allergy Relief
Liquid Medication
DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg
Antihistamine
alcohol and sugar free
Relief of:
- Sneezing;
- runny nose;
- itchy, watery eyes;
- itchy throat
Cherry Flavored
Sugar & Alcohol free
Actual Product size on Side Panel
Single Dose
10 SINGLE DOSE VIALS
This is not a child-resistant package. Keep out of reach of children
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children’s Benadryl® Dye –Free Allergy.
TAMPER EVIDENT: DO NOT USE IF ANY INDIVIDUAL SINGLE-DOSE BLISTER UNIT IS BROKEN OR OPEN
Distributed by: CVS Pharmacy, Inc.
One CVS Drive,Woonsocket, RI 02895
© 2015CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in the U.S.A.
V-12431
CVS Quality
Money Back Guarantee
SNAP BACK AT PERFORATION LINE
POUR INTO MOUTH OR SPOON
- Use scissors to cut blister if difficult to open.
-
INGREDIENTS AND APPEARANCE
CVS HEALTH CHILDRENS ALLERGY RELIEF
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-793 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 in 5 mL Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) glycerin (UNII: PDC6A3C0OX) POTASSIUM CITRATE (UNII: EE90ONI6FF) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-793-10 10 in 1 CARTON 09/07/2015 1 5 mL in 1 VIAL, SINGLE-DOSE; 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 09/07/2015 Labeler - CVS Pharmacy,Inc. (062312574)
