Cold and Allergy

Label at a glance#

Contacts and useful links#

PhoneLabel contact1-877-753-3935

Websitewww.mygnp.comwww.mygnp.com

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by a fever

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• take every 4 hours
• do not take more than 6 doses in 24 hours

adults and children 12 years of age and older	take 1 tablet
children 6 to under 12 years of age	take 1/2 tablet
children under 6 years of age	consult a doctor
children under 4 years of age	do not use

Other information

OTHER SAFETY INFORMATION

• store at 15º-30ºC (59º-86ºF) 

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, pregelatinized corn starch, sodium starch glycolate and stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to Maximum Strength Actifed® Cold & Allergy active ingredients

Does not contain Pseudoephedrine

Maximum Strength Cold & Allergy

chlorpheniramine maleate 4 mg & phenylephrine HCl 10 mg

Antihistamine / Nasal Decongestant

• Runny Nose
• Sneezing
• Itchy, Watery Eyes
• Nasal Congestion

tablets / one table dose

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Actifed® Cold & Allergy

TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed By AmerisourceBergen

1300 Morris Drive, Chesterbrook, PA 19087

Visit us at www.mygnp.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

• Cold and Allergy Maximum Strength
• Chlorpheniramine maleate, Phenylephrine HCl
• CHLORPHENIRAMINE MALEATE
• CHLORPHENIRAMINE
• PHENYLEPHRINE HYDROCHLORIDE
• PHENYLEPHRINE
• SILICON DIOXIDE
• CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
• HYPROMELLOSES
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• MINERAL OIL
• STARCH, CORN
• SODIUM STARCH GLYCOLATE TYPE A CORN
• STEARIC ACID

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 236 matching rows.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.