DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet 
AAA Pharmaceutical, 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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Diphenhydramine HCl Tablets

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

helps to reduce difficulty falling asleep

Warnings

Do not use

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

Ask a 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 avoid alcoholic drinks

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1, magnesium stearate, microcrystalline cellulose

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 16 Tablet Blister Pack Carton

RESTORE u

NDC 57344-019-01

COMPARE TO THE ACTIVE
INGREDIENT IN SOMINEX®

Get To Sleep Safely,
Wake Up Refreshed

Somnitabs
NIGHTTIME SLEEP-AID

Diphenhydramine HCl

16 TABLETS - 25 mg each

PRINCIPAL DISPLAY PANEL - 16 Tablet Blister Pack Carton
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-019
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 93XF;57344
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57344-019-01 2 in 1 CARTON
1 8 in 1 BLISTER PACK
2 NDC:57344-019-02 4 in 1 CARTON
2 8 in 1 BLISTER PACK
3 NDC:57344-019-03 9 in 1 CARTON
3 8 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part338 12/15/2012
Labeler - AAA Pharmaceutical, Inc. (181192162)
Establishment
Name Address ID/FEI Business Operations
AAA Pharmaceutical, Inc. 181192162 MANUFACTURE(57344-019)
Establishment
Name Address ID/FEI Business Operations
AAA Pharmaceutical, Inc. 010411533 PACK(57344-019)

Revised: 12/2012
Document Id: b70eecaa-44d5-4b55-9247-c6f33b6b5e74
Set id: c40a3421-9004-4694-a170-4c4daa0e94a4
Version: 1
Effective Time: 20121221
 
AAA Pharmaceutical, Inc.