IGUALTUSS- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Igualtuss by

Drug Labeling and Warnings

Igualtuss by is a Otc medication manufactured, distributed, or labeled by Alternative Pharmacal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each 5 mL tsp.)              Purpose

Dextromethorphan HBr ............... 28 mg ................ Cough Suppressant

Guaifenesin .............................. 388 mg ................ Expectorant

Phenylephrine HCl ..................... 10 mg ................... Nasal Decongestant

PURPOSE

Purpose 

Cough Suppressant

Expectorant

Nasal Decongestant

WARNINGS

Warnings

Do not use 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 you are taking a prescription drug that contains an MAOI; ask your doctor or pharmacist before taking this product.

Ask a doctor before use if you have

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

Ask a doctor before use if you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

Stop use and ask a doctor if

• 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 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.

INDICATIONS & USAGE

Uses

• temporarily 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 releives nasal congestion due to the common cold.

DOSAGE & ADMINISTRATION

Directions  Do not exceed more than 4 doses in 24 hours.

Adults and children over 12 years of age                   take 1 teaspoonful (5 mL) every 6-8 hours

Children 6 to under 12 years of age                          take 1/2 teaspoonful (2.5 mL) every 6-8 hours

Children under 6 years of age                                   consult a doctor before use

INACTIVE INGREDIENT

Inactive ingredients: Citric acid, FD&C Yellow #6, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

QUESTIONS

Questions or comments? 1-786-507-1566

Monday-Friday 9:00AM -5:00PM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IGUALTUSS 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53163-106
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	28 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	388 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color		Score
Shape		Size
Flavor	grape	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53163-106-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2014

Labeler - Alternative Pharmacal Corporation (078528214)