TUSNEL PEDIATRIC DM- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Tusnel Pediatric by

Drug Labeling and Warnings

Tusnel Pediatric by is a Otc medication manufactured, distributed, or labeled by Llorens Pharmaceutical International Division, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

In each 5 mL

Dextromethorphan HBr - 5 mg

Guaifenesin - 75 mg

Phenylephrine HCl - 2.5 mg

PURPOSE

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE

Uses

• temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
• helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to the common cold

WARNINGS

Warnings

Do not use if your child is taking a 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargment of prostate gland
• a cough with too much phlegm (mucus)
• a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor before use if your child is

• taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

Stop use and ask a doctor if your child gets

• nervousness, dizziness, or sleeplessness occur
• cough lasts for more than 7 days, comes back or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a doctor before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental overdose, seek advice of a doctor or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions: Do not exceed 6 doses in 24 hour

• Age: Dose
• Children 6 to under 12 years of age: Take 2 teaspoonful (10 mL) every 4 hours
• Children 2 to under 6 years of age: Take 1 teaspoonful (5 mL) every 4 hours
• Children under 2 years of age: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients: artificial and natural flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.

QUESTIONS

Questions or Comments? 1-866-595-5598

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TUSNEL PEDIATRIC  DM
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-604
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	75 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-604-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/01/2019

Labeler - Llorens Pharmaceutical International Division, Inc. (037342305)

Registrant - Llorens Pharmaceutical International Division, Inc. (037342305)

Establishment
Name	Address	ID/FEI	Business Operations
Llorens Pharmaceutical International Division, Inc.		037342305	manufacture(54859-604)