Family Care Cold and Flu Multi Symptom Relief SGC Daytime

Manufacturer
PHIL Inter Pharma Co., Ltd.
Effective date
2017-12-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:05:55

Label at a glance#

ProductFamily Care Cold and Flu Multi Symptom Relief SGC Daytime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure7 sections

Indications and 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

Dosage and administration

• 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

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138936027006713GTIN-13: 8936027006713
EAN-13: 8936027006713
GTIN storage (14 digits): 08936027006713
Label.jpg

Products#

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DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71038-10171038-101-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c4414da8-e7a0-19ec-e053-2a95a90affabbb2c505a-43a3-4aaa-873f-96a21f5f98d02021-06-08WarningsExact identifier
spl set id: bb2c505a-43a3-4aaa-873f-96a21f5f98d0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.