Vanacof Xp Cough / Chest Congestion

Vanacof Xp Cough / Chest Congestion
SPL v5
SPL
SPL Set ID 0b3a8cc1-a49f-e1e5-e063-6394a90a1c06
Route
ORAL
Published
Effective Date 2023-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (396 mg) Dextromethorphan (18 mg)
Inactive Ingredients
Sodium Citrate Menthol Xanthan Gum Sorbitol Sodium Benzoate Anhydrous Citric Acid Glycerin Sucralose Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-06

Description

Dextromethorphan HBr 18 mg Guaifenesin 396 mg

Purpose

Cough Suppressant Expectorant


Medication Information

Purpose

Cough Suppressant

Expectorant

Description

Dextromethorphan HBr 18 mg Guaifenesin 396 mg

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

Section 42229-5

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

Section 44425-7

■ store at 20° to 30°C (68° to 86°F)

Section 51945-4

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

Directions
  • ■ do not take more than 6 doses in any 24-hour period
  • ■ dose as follows or as directed by a doctor ■ mL= milliliter
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.

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.

Other Information

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

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

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.

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)
Active Ingredients (in Each 15 Ml (1tbsp))

Dextromethorphan HBr 18 mg

Guaifenesin 396 mg


Structured Label Content

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

Section 42229-5 (42229-5)

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

Section 44425-7 (44425-7)

■ store at 20° to 30°C (68° to 86°F)

Section 51945-4 (51945-4)

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

Purpose

Cough Suppressant

Expectorant

Directions
  • ■ do not take more than 6 doses in any 24-hour period
  • ■ dose as follows or as directed by a doctor ■ mL= milliliter
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.

Do Not Use (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.

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

When Using This Product (When using this product)

do not use more than directed

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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)
Active Ingredients (in Each 15 Ml (1tbsp)) (Active Ingredients (in each 15 mL (1TBSP)))

Dextromethorphan HBr 18 mg

Guaifenesin 396 mg


Advanced Ingredient Data


Raw Label Data

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