ZICAM- acetaminophen, dextromethorphan hydrobromide and guaifenesin liquid 
Matrixx Initiatives, 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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ZICAM®
Multi-Symptom
COLD & FLU
DAYTIME

Drug Facts

Active ingredients
(in each 30mL = 2 tablespoons)
Purpose
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant

Uses

Temporarily relieves common cold and flu symptoms:

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • sore throat
  • muscular aches
  • headache
  • fever

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 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
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema
  • a sodium restricted diet

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

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

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

DAYTIME

NDC 62750-022-10

ZICAM®
Multi-Symptom
COLD & FLU

Acetaminophen (Pain Reliever, Fever Reducer)
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)
See new warnings information.

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

8 FL OZ
(240 mL)

500884.004

Principal Display Panel - 240 mL Bottle Label
ZICAM 
acetaminophen, dextromethorphan hydrobromide and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62750-022
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D) acetaminophen325 mg  in 15 mL
dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS) dextromethorphan hydrobromide10 mg  in 15 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium (UNII: 23OV73Q5G9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62750-022-10240 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product07/16/200709/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/16/200709/15/2017
Labeler - Matrixx Initiatives, Inc. (790037253)

Revised: 9/2017
 
Matrixx Initiatives, Inc.