Guaifenesin GUAIFENESIN ONCOR PHARMACEUTICALS FDA Approved Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
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Substance Guaifenesin
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL teaspoonful) Guaifenesin 100 mg
Inactive Ingredients
Inactive ingredients Citric acid Cherry flavor FD&C red No. 40 glycerin propylene glycol purified water sodium benzoate sodium citrate sodium sorbitol solution sucralose.
Strengths
5 ml 100 mg
Quantities
5 ml 473 ml
Treats Conditions
Uses Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Make Coughs More Productive

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0383720503168
UNII
495W7451VQ
Packaging

PRINCIPAL DISPLAY PANEL NDC 83720-503-16 ONCOR PHARMACEUTICALS Guaifenesin Oral Solution USP 100 mg/5 mL Expectorant Relieves Chest Congestion Sugar Free • Alcohol Free Cherry Flavor 16 fl. oz. - 473 mL Label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 83720-503-16 ONCOR PHARMACEUTICALS Guaifenesin Oral Solution USP 100 mg/5 mL Expectorant Relieves Chest Congestion Sugar Free • Alcohol Free Cherry Flavor 16 fl. oz. - 473 mL Label

Overview

Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Indications & Usage

Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Dosage & Administration

Directions do not take more than 6 doses in any 24-hour period Age Dose Adults and Children 12 years and over 2-4 Teaspoonfuls every 4 hours Children 6 years to under 12 years 1-2 Teaspoonfuls every 4 hours Children 2 years to under 6 years 1/2-1 Teaspoonful every 4 hours Under 2 years Ask a doctor Drug Facts (continued)

Warnings & Precautions
Warnings Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) 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 persistent headache. These could be signs of a serious condition. 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.
Purpose

Purpose Expectorant

Stop Use & Ask a Doctor

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

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.

Storage & Handling

Other information store at 20°-25°C (68°-77°F) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. sodium content 3 mg/5 mL

Questions

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. Manufactured for: Oncor Pharmaceuticals 8815 Center Park Dr. Suite 430 Columbia, Maryland 21045


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