Family Care Cold And Flu Multi Symptom
FDA Label NDC 65923-627

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Family Care Cold And Flu Multi Symptom (NDC 65923-627). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

Image Description (627)

Image Description (627)

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