ALTIDOME DMX- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Altidome by

Drug Labeling and Warnings

Altidome 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 ............... 30 mg ................ Cough Suppressant

Guaifenesin .............................. 200 mg ................ Expectorant

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

PURPOSE

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

WARNINGS

Warnings

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

When using this product, do not use more than directed

Stop use and ask doctor if

• you get nervous, dizzy or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition

DO NOT USE

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 a doctor or pharmacist before taking this product

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• temporarily relieves these symptoms occuring with a cold: nasal congestion, cough due to the common cold and bronchial irritation.

DOSAGE & ADMINISTRATION

Directions  Do not exceed more than 4 doses in any 24-hour period

Adults and children 12 years of age and over            5 mL (1 tsp) every 6 hours

Children under 12 years of age                                  consult physician

INACTIVE INGREDIENT

Inactive ingredients: Citric acid, eucalyptus oil, flavors, menthol, methyl paraben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate and sucralose.

QUESTIONS

Questions or comments? 1-786-507-1566

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALTIDOME  DMX
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53163-251
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Cherry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53163-251-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/01/2013

Labeler - Alternative Pharmacal Corporation (078528214)