ALTIDESP- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops

Altidesp by

Drug Labeling and Warnings

Altidesp 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 1 mL)                Purpose

Dextromethorphan HBr............ 5 mg............. Cough Suppressant

Guaifenesin.......................... 50 mg............. Expectorant

Phenylephrine HCl................ 2.5 mg.............. Nasal Decongestant 

PURPOSE

Cough Suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
• temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold.

WARNINGS

Warnings

Do not exceed recommended dosage

If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

Do not use this product: for persistent or chrnoic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor. 

In a chlid who is taking a prescription Monoaminooxidase Inhibito (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if your child's prescription drug contains an MAOI, ask a doctor or phamacist before giving this product.

Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.

Stop use and ask a doctor before use if:

• A persistent cough may be a sign of a serious condition
• If cough persists for more than one week, tend to recur, or is accompanied by fever, rash or persistent heachache, consult a doctor.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health profession 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.

DOSAGE & ADMINISTRATION

Directions 

• Do not use more than 6 doses in any 24 hour period
• Measure with dosage device provided. Do not use with any other device

• Age: Dose
• Children 2 years to under 6 years of age: 1 mL every 4 hours
• Children under 2 years of age: consult a doctor

OTHER SAFETY INFORMATION

Other Information

Store at room temperature 150 - 300C (590-860F)

Tamper Evident Feature: Do not use if seal is torn, broken or missing.

INACTIVE INGREDIENT

Inactiveingredients

 calcium saccharin, citric acid, flavors, glycerin, methylparaben, propylene glycol, propylparaben, purified water and sodium citrate

QUESTIONS

Questions or comments? 1-786-507-1566

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALTIDESP 
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53163-108
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 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN CALCIUM (UNII: 5101OP7P2I)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53163-108-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2015

Labeler - Alternative Pharmacal Corporation (078528214)