DEXTROMETHORPHAN HBR 15 MG LIQUID GELS- dextromethorphan hbr capsule, liquid filled

Dextromethorphan HBr 15 mg Liquid Gels by

Drug Labeling and Warnings

Dextromethorphan HBr 15 mg Liquid Gels by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES, Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each softgel)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough Suppressant

Use

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

Warnings

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

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 (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

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

• adults and children12 years and older: take 2 softgels; every 6 to 8; hours, as needed
• children under12 years: do not use

Other information

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

Inactive ingredients

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene gycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-645-2158

SPL UNCLASSIFIED SECTION

Rugby®

Compare to the active ingredient in Robitussin® CoughGels®*

ADULT

Relieves:
Cough for up to 8 hours
Non-Drowsy

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Robitussin® CoughGels®.

Distributed by:
RUGBY® LABORATORIES
Livonia, MI 48152
www.rugbylaboratories.com

Product of UAE

Packaged and Quality
Assured in the USA

Packaging

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN HBR 15 MG LIQUID GELS 
dextromethorphan hbr capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1334
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	778
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1334-34	20 in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/04/2021

Labeler - RUGBY LABORATORIES (079246066)