Cheratussin Ac

Cheratussin Ac
SPL v2
SPL
SPL Set ID 3c1b7544-cc9e-43a4-ab3a-dd410af6cd56
Route
ORAL
Published
Effective Date 2009-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Codeine (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Alcohol Caramel Citric Acid Monohydrate Fd&c Red No. 40 Glycerin Menthol Water Saccharin Sodium Sodium Benzoate Sorbitol

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH FINAL Active Since 1996-09-01

Description

Codeine phosphate, USP 10 mg Guaifenesin, USP 100 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Codeine phosphate, USP 10 mg Guaifenesin, USP 100 mg

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • calms the cough control center and relieves coughing
Section 42229-5

Made in the USA

for Qualitest Pharmaceuticals

Huntsville, AL 35811

Rev. 11/09 R6 8081202 1075

Section 50566-9

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.

Section 50567-7

When using this product constipation may occur or be aggravated

Section 50569-3

Ask a doctor before use if you have

  • cough that occurs with excessive phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 50570-1

Do not use

  • in a child under 2 years of age
  • if you or your child has a chronic pulmonary disease or shortness of breath
  • if your child is taking other drugs, unless directed by a doctor
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • take every 4 hours
  • do not take more than 6 doses in any 24-hour period

adults and children 12 years and over

take 10 mL (2 tsp)

children 6 years to under 12 years

take 5 mL (1 tsp)

children 2 years to under 6 years

consult a doctor

children under 2 years

do not use

Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other Information

store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive Ingredients

alcohol, caramel, citric acid, FD&C red #40, flavor, glycerin, menthol racemic, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Principal Display Panel


NDC 55045-1495-09

Keep Out of Reach of Children.

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

Active Ingredients (in Each 5 Ml = 1 Tsp)

Codeine phosphate, USP 10 mg

Guaifenesin, USP 100 mg


Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • calms the cough control center and relieves coughing
Section 42229-5 (42229-5)

Made in the USA

for Qualitest Pharmaceuticals

Huntsville, AL 35811

Rev. 11/09 R6 8081202 1075

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product constipation may occur or be aggravated

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • cough that occurs with excessive phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 50570-1 (50570-1)

Do not use

  • in a child under 2 years of age
  • if you or your child has a chronic pulmonary disease or shortness of breath
  • if your child is taking other drugs, unless directed by a doctor
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Cough suppressant

Expectorant

Directions
  • take every 4 hours
  • do not take more than 6 doses in any 24-hour period

adults and children 12 years and over

take 10 mL (2 tsp)

children 6 years to under 12 years

take 5 mL (1 tsp)

children 2 years to under 6 years

consult a doctor

children under 2 years

do not use

Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other Information (Other information)

store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive Ingredients (Inactive ingredients)

alcohol, caramel, citric acid, FD&C red #40, flavor, glycerin, menthol racemic, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Principal Display Panel (PRINCIPAL DISPLAY PANEL)


NDC 55045-1495-09

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.

Active Ingredients (in Each 5 Ml = 1 Tsp) (Active ingredients (in each 5 mL = 1 tsp))

Codeine phosphate, USP 10 mg

Guaifenesin, USP 100 mg


Advanced Ingredient Data


Raw Label Data

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