ALKA-SELTZER PLUS  ALLERGY- diphenhydramine hydrochloride tablet 
Bayer HealthCare LLC, Consumer Care

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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Alka-Seltzer
Plus®
ALLERGY
FAST RELIEF FORMULA

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses

Warnings

Do not use to sedate children.

Do not use

  • with any other product containing diphenhydramine, even one used on the skin
  • in children under 12 years of age

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

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

When using this product

  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • use caution 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.

Directions

Other information

Inactive ingredients

croscarmellose sodium, D&C red #27, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

1-800-986-0369
(Mon-Fri 9AM - 5PM EST) or www.alkaseltzerplus.com

Distributed by:
Bayer HealthCare LLC
Consumer Care
P.O. Box 1910
Morristown, NJ 07962-1910 USA

PRINCIPAL DISPLAY PANEL - 24 Tablet Carton

Same active ingredient as Benadryl®

NEW!

Alka-Seltzer
Plus
®

ALLERGY
FAST RELIEF FORMULA

Diphenhydramine HCl 25mg
Antihistamine

Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat

24
TABLETS

BAYER

Principal Display Panel - 24 Tablet Carton
ALKA-SELTZER PLUS   ALLERGY
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0280-1175
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium 
D&C red No. 27 
dibasic calcium phosphate dihydrate 
magnesium stearate 
Cellulose, Microcrystalline 
polyethylene glycol 400 
Polyvinyl alcohol 
Talc 
titanium dioxide 
Product Characteristics
ColorPINK (Fuscia) Scoreno score
ShapeOVALSize11mm
FlavorImprint Code 25;
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-1175-242 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:0280-1175-484 in 1 CARTON
212 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33611/07/2011
Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 10/2011
Document Id: ede350c3-0bdb-4f25-8c2b-a886da1fddf5
Set id: 3e8446cc-5cd9-44e6-8bcd-125a61cd5a41
Version: 1
Effective Time: 20111005
 
Bayer HealthCare LLC, Consumer Care