Maxi-tuss Ac

Maxi-tuss Ac
SPL v1
SPL
SPL Set ID 4df08753-dc51-41f4-a8a7-11a76b318b02
Route
ORAL
Published
Effective Date 2020-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Codeine Anhydrous (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Methylparaben Potassium Citrate Propylparaben Propylene Glycol Water Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-08-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • your cough to help you sleep
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9

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

Section 55105-1
Active ingredients (in each 5 mL = 1 tsp) Purpose
Codeine phosphate, USP 10 mg Antitussive
Guaifenesin, USP 100 mg Expectorant
Directions
  • do not exceed 6 doses in 24 hours.
Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor.
Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor.
Children under 6 years of age: Consult a doctor.
Other Information

Store at controlled room temperature 15°-30°C (59°-86°F).

Inactive Ingredients

Cherry flavor, citric acid, methylparaben, potassium citrate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.

Questions Or Comments?

Call 352.754.8587

When Using This Product
  • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
  • may cause or aggravate constipation
Stop Use and Ask A Doctor If
  • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.
Ask Your Doctor Before Use If
  • you have a persistent cough, this may be a sign of a serious condition
  • you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • you have a cough that is accompanied by excessive phlegm (mucus)
  • you have chronic pulmonary disease or shortness of breath
  • giving to a child who is taking other drugs
Principal Display Panel 473 Ml Bottle Label

NDC: 58605-313-16

Maxi-Tuss AC

Antitussive/Expectorant

• Sugar Free • Alcohol Free

• Dye Free • Gluten Free

Each 5 mL (1 teaspoonful) contains:

Codeine phosphate, USP 10 mg

Guaifenesin, USP 100 mg

Caution: For manufacturing, processing,

or repackaging. This is a bulk container;

not intended for household use.

Tamper evident by

foil seal under cap.

Do not use if foil seal

is broken or missing.

Manufactured for:

MCR American Pharmaceuticals, Inc.

Brooksville, FL 34604

16 fl. oz. (473 mL)


Structured Label Content

Uses
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • your cough to help you sleep
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each 5 mL = 1 tsp) Purpose
Codeine phosphate, USP 10 mg Antitussive
Guaifenesin, USP 100 mg Expectorant
Directions
  • do not exceed 6 doses in 24 hours.
Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor.
Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor.
Children under 6 years of age: Consult a doctor.
Other Information (Other information)

Store at controlled room temperature 15°-30°C (59°-86°F).

Inactive Ingredients (Inactive ingredients)

Cherry flavor, citric acid, methylparaben, potassium citrate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.

Questions Or Comments? (Questions or Comments?)

Call 352.754.8587

When Using This Product (When using this product)
  • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
  • may cause or aggravate constipation
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.
Ask Your Doctor Before Use If (Ask your doctor before use if)
  • you have a persistent cough, this may be a sign of a serious condition
  • you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • you have a cough that is accompanied by excessive phlegm (mucus)
  • you have chronic pulmonary disease or shortness of breath
  • giving to a child who is taking other drugs
Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

NDC: 58605-313-16

Maxi-Tuss AC

Antitussive/Expectorant

• Sugar Free • Alcohol Free

• Dye Free • Gluten Free

Each 5 mL (1 teaspoonful) contains:

Codeine phosphate, USP 10 mg

Guaifenesin, USP 100 mg

Caution: For manufacturing, processing,

or repackaging. This is a bulk container;

not intended for household use.

Tamper evident by

foil seal under cap.

Do not use if foil seal

is broken or missing.

Manufactured for:

MCR American Pharmaceuticals, Inc.

Brooksville, FL 34604

16 fl. oz. (473 mL)


Advanced Ingredient Data


Raw Label Data

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