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Sudafed

Last reviewed on RxList: 8/20/2015
Drug Description

SUDAFED
(pseudoephedrine hydrochloride) Coated Tablets

DESCRIPTION

Drug Facts

Active ingredient (in each tablet): Pseudoephedrine HCl 30 mg

For Consumers

What are the possible side effects of pseudoephedrine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using pseudoephedrine and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeat;
  • severe dizziness or anxiety;
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
  • dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing,...
Indications & Dosage

INDICATIONS

Nasal Decongestant Uses

DOSAGE AND ADMINISTRATION

Directions

adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours
  • do not take more than 8 tablets in 24 hours
children ages 6 to 11 years
  • take 1 tablet every 4 to 6 hours
  • do not take more than 4 tablets in 24 hours
children under 6 years
  • do not use this product in children under 6 years of age

HOW SUPPLIED

Other Information

  • store between 20 - 25°C (68 - 77°F)
  • do not use if carton is opened or if blister unit is broken
  • see side panel for lot number and expiration date

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, shellac, sodium starch glycolate, talc, titanium dioxide

Questions or comments?

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

Pseudoephedrine HCl, Nasal Decongestant

NDC 50580-545-24

SINUS PRESSURE + CONGESTION

MAXIMUM STRENGTH

24 TABLETS - 30 mg EACH

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Side Effects & Drug Interactions

SIDE EFFECTS

No information provided.

DRUG INTERACTIONS

No information provided.

Warnings & Precautions

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

Ask a doctor before use if you have

When using this product do not exceed recommended dose

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. (1-800-222-1222)

PRECAUTIONS

No information provided.

Overdosage & Contraindications

OVERDOSE

No information provided.

CONTRAINDICATIONS

No information provided.

Medication Guide

PATIENT INFORMATION

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

When using this product do not exceed recommended dose

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. (1-800-222-1222)

FDA Logo

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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