Cold and Allergy

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 10 mg
Chlorpheniramine maleate 4mg

Purpose

OTC - PURPOSE SECTION

Nasal Decongestant
Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves nasal congestion due to the common cold, and these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion
• sinus congestion and pressure

Warnings

WARNINGS SECTION

Do Not Use

OTC - DO NOT USE SECTION

if you are now taking a prescription monoamine oxadise 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

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

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
• may cause excitability, especially in children
• may cause drowsiness; alcohol, sedatives or tranquilizers may increase drowsiness 
• avoid alcoholic beverages and use caution  when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: 1 tablet every 4 to 6 hours. Do not take more than 6 doses in 24 hours
Children under 12 years of age: Consult a doctor

Other Information

OTHER SAFETY INFORMATION

• store at room temperature
• do not use if blister unit is torn or open

Inactive Ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

• Cold and Allergy
• Phenylephrine HCl and Chlorpheniramine maleate
• PHENYLEPHRINE HYDROCHLORIDE
• PHENYLEPHRINE
• CHLORPHENIRAMINE MALEATE
• CHLORPHENIRAMINE
• SILICON DIOXIDE
• MAGNESIUM STEARATE
• STEARIC ACID
• CROSCARMELLOSE SODIUM
• MICROCRYSTALLINE CELLULOSE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

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.