DRX CHOICE CHILDRENS ALLERGY CHEWS- diphenhydramine hcl tablet, chewable 
RARITAN PHARMACEUTICALS INC

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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DRx Choice children’s allergy chews

Active ingredient (in each tablet)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.
runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Warnings

Do not use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Ask your doctor before use if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Directions

chew one tablet completely at the onset of symptoms. Do not swallow tablets whole.
Find right dose on chart below
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 (chewable tablets)

children under 2 years of age

do not use 

children 2 to under 5 years of age

do not use unless directed by a doctor 

children 6 to under 12 years of age 

1 to 2 tablets 

adults and children 12 years of age and over

2 to 4 tablets

Other information

store below at room temperature. Avoid high humidity. Protect from light.

Inactive ingredients

citric acid, crospovidone, D&C Red No.30, dextrose, FD&C Blue No 1, flavors, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose

Questions or comments ?

 1-866-467-2748

Principal Display Panel

NDC 68163-012-48

Compare to active ingredient in Children's Benadryl® Allergy Chewable Tablets

DRx Choice

children's allergy chews
diphenhydramine HCl, 12.5 mg/ antihistamine

For Relief of:

Sneezing
Runny nose
Itchy throat or Nose
Itchy, watery eyes

48 Chewable Tablets

Grape Flavor

4-6 HOURS/DOSE

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson & Johnson Consumer INC, owner of the registered trademark Children's Benadryl® Allergy Chewable Tablets.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick,

NJ 08816

IMPORTANT: Keep this carton for future reference on full labelling

DRx Choice Children's allergy Chews 48 Tablets
DRX CHOICE CHILDRENS ALLERGY CHEWS 
diphenhydramine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPURPLEScore2 pieces
ShapeROUNDSize16mm
FlavorGRAPEImprint Code RP012
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-012-484 in 1 CARTON07/04/2022
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/04/2022
Labeler - RARITAN PHARMACEUTICALS INC (127602287)

Revised: 9/2023
Document Id: ba4c5b20-6a7b-4cac-83d9-23a4c8291f77
Set id: dd2be906-bd0a-437c-9693-54b9391a5da3
Version: 2
Effective Time: 20230902
 
RARITAN PHARMACEUTICALS INC