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Drug Facts
Maxi-tuss Ac
FDA Label NDC 58605-313
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mcr American Pharmaceuticals, Inc. for the product Maxi-tuss Ac (NDC 58605-313). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, ask your doctor before use if, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 5 mL = 1 tsp) | Purpose |
|---|---|
| Codeine phosphate, USP 10 mg | Antitussive |
| Guaifenesin, USP 100 mg | Expectorant |
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.
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
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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).
Questions Or Comments?
Call 352.754.8587
Inactive Ingredients
Cherry flavor, citric acid, methylparaben, potassium citrate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.
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)
Principal Display Panel (473 mL Bottle Label)
* Please review the disclaimer below.
