FDA Label for Family Care Cold And Flu Multi Symptom

View Indications, Usage & Precautions

Family Care Cold And Flu Multi Symptom Product Label

The following document was submitted to the FDA by the labeler of this product United Exchange Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients (in each 15 mL dose cup)                                               Purpose

Acetaminophen 325 mg................................................Pain reliever/fever reducer

Dextromethorphan HBr 10 mg..................................................cough suppressant

Phenylephrine HCI 5 mg.........................................................Nasal decongestant


Otc - Purpose



Uses temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever

Warnings



Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if

  • adult takes more than 4 (30 mL each) doses in 24 hours, which is the maximum daily amount for this product
  • child takes more than 4 doses (15 mL each) in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
  • Sore throat warning: if sore throat is sever, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


Otc - Do Not Use



Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). 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.

Otc - Ask Doctor



Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland
  • a sodium-resitricted diet

Otc - Ask Doctor/Pharmacist



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


Otc - When Using



When using this product

  • do not use more than directed

Otc - Stop Use



Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. Overdose warning: Taking more than directed 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 & for children even if you do not notice any signs or symptoms.


Indications & Usage



Directions

  • take only as directed - see Overdose warning
  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hrs
  • adults & children 12 yrs over: 30 mL (2TBSP) every 4 hours

    children 6 to under 12 yrs: 15 mL(1 TBSP) every 4 hours

    children 4 to under 6 yrs: ask a doctor

    children under 4 yrs: do not use


Storage And Handling



Other information

  • each 15 mL dose cup contains: sodium 25 mg
  • store at room temperature

Inactive Ingredient



Inactive ingredients

citric acid hydrate, D-sorbitol, FD&C Yellow No. 6, glycerin, L-menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium chloride, sodium citrate hydrate, sodium saccharin, xanthan gum


Dosage & Administration



Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

Made in Korea


Package Label.Principal Display Panel




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