DEXTROMETHORPHAN HYDROBROMIDE capsule, liquid filled

Dextromethorphan Hydrobromide by

Drug Labeling and Warnings

Dextromethorphan Hydrobromide by is a Otc medication manufactured, distributed, or labeled by Softgel Healthcare Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each soft gelatin capsule)

Dextromethorphan HBr, USP 15 mg

PURPOSE

Purpose

Cough suppressant

INDICATIONS & USAGE

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

WARNINGS

Warnings

DO NOT USE

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

ASK DOCTOR

Ask a doctor before use if you have

• a cough that occurs with too much phlegm (mucus)
• a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

STOP USE

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• do not take more than 8 capsules in any 24-hour period
• this adult product is not intended for use in children under 12 years of age

• age: dose
• adults and children 12 years and over: take 2 capsules every 6 to 8 hours, as needed
• children under 12 years: do not use

OTHER SAFETY INFORMATION

Other information

• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)
• protect from light

INACTIVE INGREDIENT

Inactive ingredients

FD & C Red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K 30, propyl gallate, propylene glycol, sorbital sorbitan solution, water

SPL UNCLASSIFIED SECTION

Do Not Use if foil is torn or missing.

Manufactured By

Softgel Healthcare Pvt. Ltd.,

Survey No. 20/1, Vandalur-Kelambakkam Road,

Pudupakkam Village, Kancheepuram District,

Tamilnadu - 603 103, India.

Mfg. Lic. No.:XXXXXXXXXXXX

Principal Display Panel

ADULT

NDC: 35916-0461-1

*Compared to the active ingredientsin Robitussin ® Long-Acting CoughGels ®

Dextromethorphan Hydrobromide Capsules, 15mg

(Cough Suppressant)

20 Softgels

Liquid Filled Capsules

Upto

8

hour

relief

Non-Drowsy Formula

For Ages 12 & Over

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN HYDROBROMIDE 
dextromethorphan hydrobromide capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-0461
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE K30 (UNII: U725QWY32X)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	red (Transparent)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-0461-1	20 in 1 BOTTLE; Type 0: Not a Combination Product	09/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/11/2024

Labeler - Softgel Healthcare Pvt Ltd (675584180)