SOMINEX MAX- diphenhydramine hcl tablet

Sominex Max by

Drug Labeling and Warnings

Sominex Max by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

(in each caplet)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

helps reduce difficultly falling asleep

Warnings

Do not use

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

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

• avoid alcoholic beverages

• be careful when driving a motor vehicle or operating machinery
  
• drowsiness will occur

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 (1-800-222-1222) right away.

Directions

• adults and children 12 years and older: take 1 caplet at bedtime if needed, or as directed by your doctor

Other information

store at room temperature 20º- 25ºC (68º-77ºF)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1 lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearate acid, talc, titanium dioxide, triacetin

Questions?

1-866-255-5202 

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH FORMULA
Sominex®
NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl
16 TABLETS

INGREDIENTS AND APPEARANCE

SOMINEX MAX 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-505
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	BLUE (light blue)	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	S
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-505-16	1 in 1 BOX	06/01/2012
1		16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 63029-505-01	1 in 1 BOX	06/01/2012	02/01/2019
2	NDC: 63029-505-07	16 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	06/01/2012

Labeler - Medtech Products Inc. (122715688)