ALTILAN CL- dextromethorphan hbr, phenylephrine hcl, chlorpheniramine maleate liquid

Altilan by

Drug Labeling and Warnings

Altilan 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)                Purpose

Dextromethorphan HBr.............. 15 mg ........ Cough suppressant

Phenylephrine HCL .................. 10 mg ...... Nasal Decongestant

Chlorpheniramine Maleate........ 4 mg ........ Antihistamine

PURPOSE

Cough suppressant

Nasal Decongestant

Antihistamine

INDICATIONS & USAGE

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

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 MAOI; ask your doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

A persistant cough may be a sign of a serious condition. If cough persists for more than a week, tends to recur, or is accompanied by fever, rash, or persistent headache.

When using this product

• do not exceed the recommended dosage
• excitability may occur, especially in children
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery

When using this prouct do not use more than directed.

Stop use and ask a doctor before use if: 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.

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 take more than 6 doses in any 24-hour period.

• Age: Dose
• Adults and children 12 years of age and over: 5 ml (1 tsp) every 4 hours
• Children 6 years to under 12 years of age: 2.5 ml (1/2 tsp) every 4 hours
• Children under 6 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other Information

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

Tamper Evident Feature: Do not use if seal under cap is torn, broken or missing. Avoid excessive heat or humidity.

INACTIVE INGREDIENT

Inactiveingredients

Cherry flavor, citric acid, glycerin, hydroxyethylcellulose, methylparaben, potssium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

QUESTIONS

Questions or comments? 1-786-507-1566

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALTILAN  CL
dextromethorphan hbr, phenylephrine hcl, chlorpheniramine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53163-114
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53163-114-16	473 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)