VANACOF XP COUGH / CHEST CONGESTION- dextromethorphan hbr, guaifenesin solution

Active Ingredients (in each 15 mL (1TBSP))

Dextromethorphan HBr 18 mg

Guaifenesin 396 mg
Purpose

Cough Suppressant

Expectorant
Uses
- ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- ■ temporarily relieves:
■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

■ the intensity of coughing

■ the impulse to cough to help you get to sleep
Warnings
Do not use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- ■ a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- ■ a cough that occurs with too much phlegm (mucus)
When using this product

do not use more than directed

Stop use and ask a doctor if

■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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

adults and children 12 years of age and over:	15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) per 24 hours
children 6 to under 12 years of age:	7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) per 24 hours
children under 6 years:	consult a doctor.

Other information

■ each 15 mL (1 TBSP) contains: Sodium 6 mg

■ store at 20° to 30°C (68° to 86°F)
Inactive ingredients

citric acid, flavors, glycerin, l-menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions or comments?

1-888-535-0305 9 a.m. - 5 p.m. CST
SPL UNCLASSIFIED SECTION

Tamper evident by foil seal under cap. Do no use if foil seal is broken or missing.

Distributed by: GM Pharmaceuticals, Inc. Fort Worth, TX 76118
PRINCIPAL DISPLAY PANEL

NDC: 58809-187-08

VANACOF® XP

COUGH / CHEST CONGESTION

Each 15 mL (1 TBSP) contains:

Dextromethorphan HBr.....18 mg

Guaifenesin ....................396 mg

Cough Suppressant ■ Expectorant

Raspberry-Mint Flavor

Alcohol Free / Sugar Free / Gluten Free / Dye Free

INGREDIENTS AND APPEARANCE

VANACOF XP COUGH / CHEST CONGESTION
dextromethorphan hbr, guaifenesin solution

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	396 mg in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	18 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CITRATE (UNII: 1Q73Q2JULR)
MENTHOL (UNII: L7T10EIP3A)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 58809-187-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	12/06/2023

Labeler - GM Pharmaceuticals, INC (793000860)

VANACOF XP Cough / Chest Congestion by