DIMETANE- diphenhydramine hydrochloride capsule, liquid filled

Dimetane by

Drug Labeling and Warnings

Dimetane by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each softgel)

Diphenhydramine HCl 25 mg & 50 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat

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

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

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

• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 doses in 24 hours

adults and children 12 years and over                      1 softgel
children under 12 years                                         do not use

Other Information

• Store between 20-25°C (68-77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) 
• Protect from moisture and light.
• Tamper Evident: do not use if foil seal under cap is broken or missing.

Inactive Ingredients

25mg:- Gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution

50mg:- FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol sorbitan solution

Questions or comments

Call 1-877-474-7464

†This product is neither manufactured nor distributed by the owner of the registered trademark Benadryl® and Liqui-Gels®

DIMETANE TM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: 10/UA/2016

PRINCIPAL DISPLAY PANEL

NDC 57237-367-99

Dimetane TM  

Diphenhydramine HCl 25 mg

Allergy Relief 

Antihistamine

Compare to the active ingredient in Benadryl ®Allergy Liqui-Gels ®† 

For the Temporary Relief of 

Runny Nose Itchy, watery eyes, Sneezing, Itchy throat or nose

NDC 57237-368-99

Dimetane TM

Diphenhydramine HCl 50 mg

Allergy Relief Extra Strength

Antihistamine

Compare to the active ingredient in Benadryl ® Allergy Liqui-Gels ®* Extra Strength®†

For the Temporary Relief of

Runny Nose Itchy, watery eyes, Sneezing, Itchy throat or nose

INGREDIENTS AND APPEARANCE

DIMETANE 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-367
Route of Administration	ORAL

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
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white (Transparent)	Score	no score
Shape	OVAL (Oblong)	Size	15mm
Flavor		Imprint Code	BZ3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-367-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2026
2	NDC: 57237-367-99	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/27/2026

DIMETANE 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-368
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	BZ9
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-368-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2026
2	NDC: 57237-368-99	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/27/2026

Labeler - Rising Pharma Holdings, Inc. (116880195)