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Zicam

Matrixx Initiatives, Inc.

ZICAM Multi-Symptom COLD & FLU NIGHTTIME


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients
(in each 30mL = 2 tablespoons)
Purpose
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Doxylamine Succinate 12.5 mg Antihistamine

Zicam Uses

temporarily relieves common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • sore throat
  • muscular aches
  • headache
  • fever
  • runny nose
  • watery eyes
  • sneezing

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 12 tablespoons in 24 hours, which is the maximum daily amount for this product
  • with any other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Sore throat warning

If sore throat is severe, persists for more than two days, is accompanied by or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other drug containing acetaminophen
    (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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

  • liver disease
  • glaucoma
  • difficulty in urination due to enlarged prostate
  • a breathing problem such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • a sodium restricted diet

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • may cause excitability especially in children
  • be careful when driving a motor vehicle or operating machinery
  • may cause marked drowsiness
  • alcohol, sedatives, and tranquilizers may intensify drowsiness effect
  • avoid alcoholic beverages

Stop use and ask a doctor if

  • redness or swelling is present
  • fever gets worse or lasts for more than 3 days
  • pain or cough get worse or do not get better within 7 days or are accompanied by a fever
  • cough comes back or occurs with rash, fever, or headache that lasts
  • new symptoms occur

These could be signs of a serious condition.

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

Keep out of reach of children.

Overdose warning

taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

  • Take only as directed – see overdose warning
  • Only use enclosed measuring cup designed for use with this product
  • Adults and children 12 years and over:
    • Take 2 tablespoons (TBSP) or 30 milliliters (mL)
    • May be added to 6-8 ounces of hot or cold beverage (tea, juice, soda)
    • Take every 4 hours as needed
    • Do not exceed 12 tablespoons in any 24 hour period
  • Children under 12 years of age: DO NOT USE

Zicam Other information

  • store at room temperature 15°-29°C (59°-84°F)
  • do not use if plastic neck wrap or foil inner seal is broken or missing
  • contains 10 mg potassium per 2 tablespoons
  • contains 30 mg sodium per 2 tablespoons

Inactive ingredients

acesulfame potassium, disodium EDTA, glycerin, hydroxyethylcellulose, polyethylene glycol, potassium sorbate, purified water, sodium chloride, sucralose

Questions? Comments? Side Effects?

call 877-942-2626 toll-free or visit us on the web at www.zicam.com

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

NIGHTTIME

NDC 62750-023-10

ZICAM®
Multi-Symptom
COLD & FLU

Acetaminophen (Pain Reliever, Fever Reducer)
Dextromethorphan HBr (Cough Suppressant)
Doxylamine Succinate (Antihistamine)
See new warnings information.

The Taste You Choose™
Virtually tasteless
when added to any beverage.

8 FL OZ
(240 mL)

500886.004

Zicam

Zicam

acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62750-023
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62750-023-10 240 in 1 BOTTLE, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-07-16


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Be sure to consult your doctor before taking any medication!
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