ALLERGY RELIEF- diphenhydramine hcl liquid 
KRAMER NOVIS

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.

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Allergy Relief

Drug Facts

Active Ingredient (in each 5 mL tsp)

Diphenhydramine HCL, 12.5 mg

Purpose

Antihistamine

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

Temporarily relieves these symptoms due to the common cold:
• runny nose • sneezing

Warnings

Do not use

• with any other product containing diphenhydramine, even one used on skin

• to make a child sleepy

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

• trouble urinating due to the enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product:

• excitability might occur, especially in children

• marked drowsiness may occur • avoid alcoholic drinks

• alcohol, sedatives, and tranquilizers may increase drowsiness effect

• be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding, ask a health professional before use.

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

Directions

• Take every 4 to 6 hours, or as directed by doctor.
Do not exceed recommended dose.

 Adults and Children 12 years of age and over: take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours
 Children 6 to under 12 years of age: take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours
 Children under 6 years of age: consult a doctor

Other information

• Store at controlled room temperature 15°-30°C (59°-86°F).

• Do not refrigerate. Avoid excessive heat or humidity.

• Protect from light. 

Inactive ingredients

Cherry flavor, citric acid, FD&C Red #40, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, and sucralose

Questions or comments?

Call weekdays from 8 AM to 4 PM AST at 1-787-767-2072 | www.kramernovis.com

Manufactured in the USA for Kramer Novis, San Juan, PR 00917

Compare to the active ingredient of Benadryl®  Allergy Liquid*

Relieves:

√  Runny Nose

√  Sneezing

√  Itchy, Watery Eyes

√  Itchy Throat

Cherry Flavor

Alcohol Free

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.

Packaging

image description

ALLERGY RELIEF 
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-665
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-665-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/02/2020
Labeler - KRAMER NOVIS (090158395)

Revised: 3/2020
Document Id: 7d392208-3e6a-484e-b6be-6faf23668c97
Set id: b055e3cc-a666-4140-b58e-face4dd76423
Version: 1
Effective Time: 20200303
 
KRAMER NOVIS