American Sales Company Children’s Mucus Relief Drug Facts

Active ingredient (in each 5 mL)

Guaifenesin 100 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Ask a doctor before use if the child has

•: cough that occurs with too much phlegm (mucus)
•: persistent or chronic cough such as occurs with asthma

Stop use and ask a doctor if

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

•: do not take more than 6 doses in any 24-hour period
•: measure only with dosing cup provided
•: do not use dosing cup with other products
•: mL = milliliter

Age	Dose
children 6 years to under 12 years	5 mL – 10 mL every 4 hours
children 4 years to under 6 years	2.5 mL – 5 mL every 4 hours
children under 4 years	do not use

Other information

•: do not use if printed neckband is broken or missing
•: store at 20-25°C (68-77°F)
•: do not refrigerate
•: dosing cup provided

Inactive ingredients

acesulfame potassium, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol solution, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Children’s Mucinex® Chest Congestion

For Ages 4 And Older

Children’s

MUCUS RELIEF

CHEST CONGESTION

Expectorant - Guaifenesin 100mg

FOR RELIEF OF:

Chest Congestion

Breaks Up Mucus

Alcohol Free

Gluten Free

OUR PHARMACISTS RECOMMEND

Grape Flavor

4 FL OZ (118mL)

CAREONE MUCUS RELIEF CHILDRENS
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-288
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	PURPLE (clear)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-288-26	1 in 1 CARTON	08/08/2007	02/28/2021
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	08/08/2007	02/28/2021

Labeler - American Sales Company (809183973)

Revised: 10/2024

Document Id: 8a6f3bd8-60f2-490c-ae65-352b10040e59

Set id: 6243d377-7a15-48ec-b7d3-32a8c9114e7b

Version: 5

Effective Time: 20241028

American Sales Company