CVP 44-525

Drug Labeling and Warnings

Drug Details [pdf]

ALLERFED- chlorpheniramine maleate, phenylephrine hcl tablet 
Salado Sales, Inc.

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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CVP 44-525

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg
Phenylephrine HCl 10 mg

Purpose

Antihistamine
Nasal decongestant

Uses

• temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other respiratory allergies:
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat
  • sneezing
  • nasal congestion
• temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing
  • nasal congestion

Warnings

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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• high blood pressure
• heart disease
• thyroid disease
• diabetes
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• do not exceed recommended dose
• drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or occur with a fever

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

• adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
• children under 12 years: do not use this product in children under 12 years of age

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid

Questions or comments?

1-800-426-9391

Principal Display Panel

 CVP®

COLD & ALLERGY
ALLERFED®

CHLORPHENIRAMINE MALEATE - ANTIHISTAMINE
PHENYLEPHRINE HCL - NASAL DECONGESTANT

24 TABLETS
1 TABLET PER DOSE

FOR TEMPORARY RELIEF
OF NASAL CONGESTION
DUE TO THE COMMON
COLD. ALLEVIATES RUNNY
NOSE, SNEEZING, ITCHY
AND WATERY EYES DUE
TO HAY FEVER.

DOES NOT CONTAIN PSEUDOEPHEDRINE

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING

50844       REV0612F52508
Distributed by Salado Sales, Inc.
P.O. Box 6115, Temple, Texas 76503
www.saladosales.com

CVP 44-525

ALLERFED 
chlorpheniramine maleate, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57243-525
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE (UNII: J2B2A4N98G)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;525
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57243-525-08	1 in 1 CARTON	07/22/2005	10/25/2019
1		24 in 1 BLISTER PACK; 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	07/22/2005	10/25/2019

Labeler - Salado Sales, Inc. (009830555)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(57243-525)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(57243-525)

Revised: 12/2016

Document Id: 1b2e6ba4-b246-4af3-8b3d-f10cd8104131

Set id: fcbbc390-cb2a-47e1-928f-9090ff75d979

Version: 3

Effective Time: 20161201