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Family Care Cold and Flu Multi Symptom Relief SGC Daytime

Medically reviewed on Dec 25, 2017

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: PHIL Inter Pharma Co., Ltd.
NDC Code: 71038-101

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.

Family Care Cold & Flu Multi Symptom Relief SGC, Daytime

Drug Facts

Active ingredient (in each softgel)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold and flu symptoms:

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

Warnings

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

take more than 4 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
skin reddening
blisters
rash If a skin reaction occurs, stop use and seek medical help right away.
Store throat warning: If sore throat is severe, persists for morethan 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use
  • with any other products 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 drugs 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 • heart disease • thyroid disease  • diabetes •  high blood pressure • trouble urinating due to an enlarged prostate gland. • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless • symptoms get worse or lasts more than 5 days (children) or 7 days (adults) • fever gets worse or lasts more than 3 days • redness or swelling is present new symptoms occur • cough come back, or occurs with rash or headache that lasts. 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.

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Directions

• take only as directed (see Warnings)

• do not exceed 4 doses per 24 hours

•  Adults and children 12 years of age and older: take 2 softgels with water every 4 hours

•  Children 4 to under 12 years: ask a doctor

Children under 4 years: do not use

Other information
  • store at room temperature
  • do not use if blister unit is torn or open

Inactive ingredients

Polyethylene glycol 600, Polyethylene glycol 400, Purified water, Povidone, Propylene glycol, Gelatin, Concentrated glycerin, D-sorbitol, Ethyl vanillin, FD&C Blue # 1, FD&C Red # 40

Package Labeling:

FAMILY CARE COLD AND FLU MULTI SYMPTOM RELIEF SGC DAYTIME 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71038-101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE5 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 600 
POLYETHYLENE GLYCOL 400 
WATER 
POVIDONE 
PROPYLENE GLYCOL 
GELATIN 
SORBITOL 
ETHYL VANILLIN 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeNONE
Contains    
Packaging
#Item CodePackage Description
1NDC:71038-101-101 BLISTER PACK in 1 BOX
110 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/23/2017
Labeler - PHIL Inter Pharma Co., Ltd. (555267773)
Establishment
NameAddressID/FEIOperations
PHIL Inter Pharma Co., Ltd.555267773manufacture(71038-101)

 
PHIL Inter Pharma Co., Ltd.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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