CHILDRENS DYE FREE ALLERGY RELIEF- diphenhydramine hcl liquid

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

PURPOSE

Purpose

Antihistamine

INDICATIONS & USAGE

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat

WARNINGS

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

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product

• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness
• excitability may occur, especially in children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DOSAGE & ADMINISTRATION

Directions

• find right dose on chart below
• mL = milliliter
• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 doses in 24 hours

• Age (yr): Dose (mL)
• 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: 5 mL to 10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

OTHER SAFETY INFORMATION

Other information

• each 5 mL contains: sodium 5 mg
• store at no greater than 25°C

INACTIVE INGREDIENT

Inactive ingredients anhydrous citric acid, flavors, glycerin, purified water, sodium benzoate, sodium carboxymethylcellulose, sodium citrate dihydrate, sodium saccharin, sorbitol solution, sucralose

QUESTIONS

Questions or comments? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

653L Children's Dye Free Allergy Relief - Bubblegum flavor - Label

653L Children's Dye Free Allergy Relief - Bubblegum flavor - Carton

INGREDIENTS AND APPEARANCE

CHILDRENS DYE FREE ALLERGY RELIEF 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-563
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
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-563-05	1 in 1 CARTON	05/01/2026
1		118 mL in 1 BOTTLE; 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	05/01/2026

Labeler - BETTER LIVING BRANDS LLC. (009137209)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		677604129	manufacture(21130-563)