Geri-Tussin: Package Insert and Label Information

GERI-TUSSIN- guaifenesin liquid
Geri-Care Pharmaceuticals, Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

In each 5 mL teaspoonful

Guaifenesin — 100 mg

Purpose

Expectorant

Uses

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

Warnings

Do not use

• if you ever had an allergic reaction to any of the ingredients in this product

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

Directions

• do not take more than 6 doses in a 24 hour period
• do not exceed recommended dose

adults and children 12 years and over	2 to 4 teaspoonfuls every 4 hours
children under 12 years	ask a doctor

Inactive ingredients:  artificial and natural cherry flavor, citric acid, FD&C red #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions or comments? 1-800-540-3765

GERI-TUSSIN guaifenesin liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-693 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg in 5 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID FD&C RED NO. 40 MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE SUCRALOSE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57896-693-16 473 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2019

Labeler — Geri-Care Pharmaceuticals, Corp (611196254)

Revised: 03/2021 Geri-Care Pharmaceuticals, Corp