ALTIDEC A- brompheniramine maleate, phenylephrine hcl liquid 
Alternative Pharmacal Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients (in each 5 mL)                Purpose

Brompheniramine Maleate ............. 2 mg ........ Antihistamine

Phenylephrine HCL .................. 5 mg ...... Nasal Decongestant

Nasal Decongestant

Antihistamine

Uses

Temporarily relieves the symptoms caused by the common cold, hay fever or other respiratory allergies; nasal congestrion, runny nose, sneezing, itchy, watery eyes, itching of the nose or throat.

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:

  • Heart disease - High blood pressure - thyroid deases - diabetes
  • Trouble urinating due to enlarged prostate gland
  • Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

When using this product do not use more than directed.

  • excitability may occur
  • drowsiness may occur
  • sedatives and tranquilizer 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. Nervouseness, dizziness or sleeplessness occurs.

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

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

Directions Do not take more than 6 doses in any 24-hour period.

 Adults and children 12 years of age and over 10 ml (2 tsp) every 4 - 6 hours
 Children 6 years to under 12 years of age 5 ml (1 tsp) every 4 - 6hours
 Children under 6 years of ageconsult a doctor

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.

Inactiveingredients

 citric acid, FD&C Blue #1, FD&C Red #40, grape flavor, glycerin, hydroxyethylcellulose, methylparaben, potssium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Questions or comments? 1-786-507-1566

Altidec-A

ALTIDEC  A
brompheniramine maleate, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53163-116
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53163-116-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/201501/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/201501/01/2017
Labeler - Alternative Pharmacal Corporation (078528214)

Revised: 1/2017
 
Alternative Pharmacal Corporation