maxi-tuss pe max

maxi-tuss pe max
SPL v1
SPL
SPL Set ID d7505224-87e6-4ce5-a76d-e7637b3f315c
Route
oral
Published
Effective Date 2020-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (100 mg) phenylephrine (5 mg)
Inactive Ingredients
citric acid monohydrate methylparaben ammonium glycyrrhizate 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

Warnings

Do not exceed recommended dosage.

Uses

temporarily relieves

  • Nasal congestion due to the common cold
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Other Information

Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

Inactive Ingredients

Citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylparaben, propylene glycol, purified water, sorbitol, sucralose

Description

Drug Facts

Section 42229-5

Drug Facts

Section 53414-9

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

Section 55105-1
Active Ingredients (in each 5 mL teaspoonful) Purpose
Guaifenesin 100 mg Expectorant
Phenylephrine HCl 5 mg Nasal Decongestant
Questions Or Comments?

Call 352.754.8587

Do Not Use This Product
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 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
Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • 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.
Keep Out of Reach of Children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Ask A Doctor Before Use If You Have
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 473 Ml Bottle Label

NDC 58605-315-16

Maxi-Tuss PE Max

Expectorant ◾ Nasal Decongestant

Sugar Free ◾ Alcohol Free ◾ Dye Free

Each teaspoonful (5 mL) for oral administration

contains:

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Grape Flavor

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

Warnings

Do not exceed recommended dosage.

Uses

temporarily relieves

  • Nasal congestion due to the common cold
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Other Information (Other information)

Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

Inactive Ingredients (Inactive ingredients)

Citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylparaben, propylene glycol, purified water, sorbitol, sucralose

Section 42229-5 (42229-5)

Drug Facts

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 teaspoonful) Purpose
Guaifenesin 100 mg Expectorant
Phenylephrine HCl 5 mg Nasal Decongestant
Questions Or Comments? (Questions or comments?)

Call 352.754.8587

Do Not Use This Product (Do not use this product)
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • 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.
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

NDC 58605-315-16

Maxi-Tuss PE Max

Expectorant ◾ Nasal Decongestant

Sugar Free ◾ Alcohol Free ◾ Dye Free

Each teaspoonful (5 mL) for oral administration

contains:

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Grape Flavor

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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