GUAIFENESIN- guaifenesin liquid
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Guaifenesin

NDC 58657-509-16

Guaifenesin

Liquid USP

100 mg/5 Ml

Expectorant

Sugar Free • Alcohol Free

Cherry Flavor

Loosens and Relieves Chest Congestion

16 fl. oz. (473 mL)

Drug Facts

Active ingredient (in each 5 mL)

Guaifenesin 100 mg

Purpose

Expectorant

Uses

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

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.

Directions

do not take more than 6 doses in any 24-hour period
age dose adults and children 2 to 4 teaspoonfuls
12 years and over every 4 hours
children 6 years to 1 to 2 teaspoonfuls
under 12 years every 4 hours
children 2 years to ½ to 1 teaspoonful
under 6 years every 4 hours
children under 2 years ask a doctor

Drug Facts (continued)

Other information

store at 20°-25°C (68°-77°F)
packaged with tamper evident seal under cap

Inactive ingredients

Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red#40, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution

Questions or Comments

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Guaifenesin

GENERIC: Guaifenesin

DOSAGE: LIQUID

ADMINSTRATION: ORAL

NDC: 70518-3283-0

NDC: 70518-3283-1

COLOR: red

FLAVOR: CHERRY

PACKAGING: 20 mL in 1 CUP, UNIT-DOSE

OUTER PACKAGING: 10 in 1 BOX

ACTIVE INGREDIENT(S):

GUAIFENESIN 100mg in 5mL

INACTIVE INGREDIENT(S):

CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CITRATE
SACCHARIN SODIUM
SORBITOL

Remedy_Label

MM2

GUAIFENESIN
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-3283(NDC:58657-509)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70518-3283-0	10 in 1 BOX	12/07/2021	05/09/2023
1	NDC:70518-3283-1	20 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		12/07/2021	05/09/2023

Labeler - REMEDYREPACK INC. (829572556)

Revised: 5/2023

Document Id: fb457a9a-4e30-42ed-e053-6294a90a31eb

Set id: a8fcd548-0a82-4bcb-8e60-ae90819506cc

Version: 2

Effective Time: 20230509

REMEDYREPACK INC.