GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE liquid

Guaifenesin and Dextromethorphan hydrobromide by

Drug Labeling and Warnings

Guaifenesin and Dextromethorphan hydrobromide by is a Otc medication manufactured, distributed, or labeled by Oncor Pharmaceuticals, Quality CDMO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

(in each 5 mL teaspoonful) Purpose

Dextromethorphan
Hydrobromide 10 mg..........Cough Suppressant
Guaifenesin 200 mg.......................Expectorant

Uses

temporarily Relieves

- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

- the intensity of coughing

- the impulse to cough to help you get to sleep

Warnings

Do not exceed recommended dosage.

Do not use this product

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

- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

- cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if

- cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Directions

do not exceed recommended dosage.

• adults and children 12 years and over: 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours or as directed by a doctor
• children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours or as directed by a doctor
• children under 6 years of age: consult a physician

Inactive ingredients

cherry flavor, citric acid, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose.

Other information

- store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

- tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

QUESTIONS

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Principal Display Panel

Oncor Pharmaceuticals

NDC: 83720-505-16

Guaifenesin and Dextromethorphan hydrobromide USP

200 mg/10 mg

Expectorant
Cough Suppressant

Non Drowsy - Alcohol Free

For Ages 12 & Up

CHERRY FLAVOR

NET WT. 16 fl. oz. (473 ml)

NDC: 83720-505-04

Guaifenesin and Dextromethorphan hydrobromide USP

200 mg/10 mg

Expectorant
Cough Suppressant

Non Drowsy - Alcohol Free

For Ages 12 & Up

CHERRY FLAVOR

NET WT. 4 OZ. (118 ml)

Manufactured In USA For :

Oncor Pharmaceuticals
6755 Business Pkwy Suite 202
Elkridge, MD 21075
United States.
Rev. 12/24

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83720-505
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	200 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
CHERRY (UNII: BUC5I9595W)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83720-505-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2025
2	NDC: 83720-505-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/01/2025

Labeler - Oncor Pharmaceuticals (119032580)

Registrant - Oncor Pharmaceuticals (119032580)

Establishment
Name	Address	ID/FEI	Business Operations
Quality CDMO		117658386	manufacture(83720-505)