GUAIASORB DM- dextromethorphan hbr, guaifenesin liquid

Guaiasorb by

Drug Labeling and Warnings

Guaiasorb by is a Otc medication manufactured, distributed, or labeled by NuCare Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (per 5 mL teaspoonful)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

PURPOSE

Purpose

• cough suppressant
• expectorant

INDICATIONS & USAGE

Uses

• temporarily relieves cough due to minor throat and bronchial irritation
• helps loosen phlegm mucus
• helps thin bronchial secretions to make coughs more productive

WARNINGS

Warnings

Do not use if you are now taking 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 with too much phlegm (mucus)
• a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or headache that lasts. 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 exceed recommended dose
• take every 4 hours as needed, or as directed by a doctor
• do not take more than 6 doses in 24 hours

• Adults and children 12 years and over: 2 teaspoonfuls (10 mL)
• Children under 12 years: Do not use

INACTIVE INGREDIENT

Inactive ingreadients artificial and natural cherry flavor, citric acid, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIASORB  DM
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68071-3938(NDC:57896-736)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68071-3938-4	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/01/2019

Labeler - NuCare Pharmaceuticals, Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals, Inc.		010632300	relabel(68071-3938)