Maxi-tuss Pe Jr

Maxi-tuss Pe Jr
SPL v1
SPL
SPL Set ID d7ad44b6-fb64-4d69-8695-2a710877359e
Route
ORAL
Published
Effective Date 2020-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (50 mg) Phenylephrine (2.5 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

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

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 50 mg Expectorant
Phenylephrine HCl 2.5 mg Nasal Decongestant
Warnings

Do not exceed recommended dosage.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over: 4 teaspoonfuls (20 mL) every 4 hours, not to exceed 24 teaspoonfuls in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age: 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor
Children under 6 years of age: Consult a physician
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

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.
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 58605-314-16

Maxi-Tuss PE Jr

Expectorant ◾ Nasal Decongestant

Sugar Free ◾ Alcohol Free ◾ Dye Free

Each teaspoonful (5 mL) for oral administration

contains:

Guaifenesin 50 mg

Phenylephrine HCl 2.5 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

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

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 50 mg Expectorant
Phenylephrine HCl 2.5 mg Nasal Decongestant
Warnings

Do not exceed recommended dosage.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over: 4 teaspoonfuls (20 mL) every 4 hours, not to exceed 24 teaspoonfuls in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age: 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor
Children under 6 years of age: Consult a physician
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

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.
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 58605-314-16

Maxi-Tuss PE Jr

Expectorant ◾ Nasal Decongestant

Sugar Free ◾ Alcohol Free ◾ Dye Free

Each teaspoonful (5 mL) for oral administration

contains:

Guaifenesin 50 mg

Phenylephrine HCl 2.5 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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