SOHMED ALLERGY- diphenhydramine hydrochloride tablet 
SOHM 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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SohMed™ Allergy

Drug Facts

Active ingredients (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

Warnings

Do not use 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

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.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over1 to 2 caplets
children 6 to under 12 years1 caplet
children under 6 yearsconsult a doctor

Other information

Inactive ingredients

croscarmellose sodium, D&C Red #27, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide, May contain polysorbate.

Question or comments?

1 (856) 2863646

Distributed by : Sohm, Inc.
6920 Knott Ave., Suit A-C,
Buena Park, CA 90621

PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

NDC XXXXXXXXXX

SohMed™
*Compare to the active ingredients in Benadryl® Allergy Ultratab®

Antihistamine

Allergy

Diphenhydramine HCl 25 mg

24 Caplets

• Runny Nose • Itchy, Watery Eyes
• Sneezing • Itchy throat

Principal Display Panel - 24 Caplet Bottle Carton
SOHMED ALLERGY 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50405-004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Product Characteristics
ColorREDScore2 pieces
ShapeOVALSize11mm
FlavorImprint Code CRX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50405-004-241 in 1 CARTON
124 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/25/2013
Labeler - SOHM Inc. (009303848)

Revised: 8/2013
Document Id: 47dc0428-8164-4ef3-97d4-47e6237dd824
Set id: 1e650657-83e5-4704-863b-c420390a2247
Version: 1
Effective Time: 20130820
 
SOHM Inc.