CORRECT DOSE  CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride liquid 
BFS Pharma, 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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Drug Facts

Active ingredient (in each 5 mL)*

Diphenhydramine HCl 12.5 mg

*5 mL = one pre-filled spoon

Purpose

Antihistamine

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 you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet

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 (1-800-222-1222).

Directions

Children under 2 years of agedo not use
Children 2 to 5 years of agedo not use unless directed by a doctor
Children 6 to 11 years of age1 to 2 pre-filled spoons (12.5 mg to 25 mg)
Adults and children 12 years of age and over2 to 4 pre-filled spoons (25 mg to 50 mg)

Other information

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions or comments?

1-877-545-3635

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributo of Children's Benadryl® Allergy Perfect Measure

PRINCIPAL DISPLAY PANEL

NDC 76103-004-10

Correct Dose
Children's
Allergy Relief
®


Diphenhydramine HCI
Oral Solution Antihistamine

Correct Dose HELPS RELIEVE

CHERRY FLAVOR

Alcohol Free

10 PRE-FILLED SINGLE USE SPOONS**
0.17 FL OZ (5 mL) EACH
**12.5 mg Diphenhydramine HCl each

Principal Display Panel
CORRECT DOSE   CHILDRENS ALLERGY RELIEF
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76103-004
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
anhydrous citric acid (UNII: XF417D3PSL)  
D&C red NO. 33 (UNII: 9DBA0SBB0L)  
FD&C red NO. 40 (UNII: WZB9127XOA)  
glycerin (UNII: PDC6A3C0OX)  
glycyrrhizin, ammoniated (UNII: 3VRD35U26C)  
poloxamer 407 (UNII: TUF2IVW3M2)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium chloride (UNII: 451W47IQ8X)  
sodium citrate (UNII: 1Q73Q2JULR)  
sucrose (UNII: C151H8M554)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76103-004-1010 in 1 CARTON
15 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/15/2011
Labeler - BFS Pharma, Inc. (967271458)

Revised: 5/2011
Document Id: ba07fb8f-073f-4f5c-8961-3ba2877971a1
Set id: d8dd70ed-37e2-4c7c-9676-dcedf7e3d5cd
Version: 1
Effective Time: 20110525
 
BFS Pharma, Inc.