TOPCARE MUCUS RELIEF- guaifenesin solution

Topcare Mucus Relief by

Drug Labeling and Warnings

Topcare Mucus Relief by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL)

Guaifenesin, USP 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?

1-888-423-0139

Principal Display Panel

COMPARE TO CHILDREN’S MUCINEX® CHEST CONGESTION ACTIVE INGREDIENT

children’s Chest Congestion

Mucus Relief

OUR PHARMACISTS RECOMMEND

EXPECTORANT - GUAIFENESIN

Relieves Chest Congestion

Breaks Up Mucus

ALCOHOL FREE

Ages 4 to 12 Years

GRAPE FLAVOR

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

TOPCARE MUCUS RELIEF 
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-288
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-288-26	1 in 1 CARTON	11/01/2007
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/01/2007

Labeler - Topco Associates LLC (006935977)