Non-Drowsy Daytime Multi-Symptom Cold and Flu description, usages, side effects, indications, overdosage, supplying and lots more!

Non-Drowsy Daytime Multi-Symptom Cold and Flu

Family Dollar

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Family Wellness 44-534

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each liquid cap)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • fever
    • cough due to minor throat and bronchial irritation

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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 don't 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
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

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

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, 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.

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 (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed
    (see overdose warning)
  • do not take more than 4 doses per 24 hours
  • adults and children 12 years and over: take 2 liquid caps with water every 6 hours
  • children under 12 years: ask a doctor

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, white edible ink

Questions or comments?

1-800-426-9391

Principal display panel

FAMILY
wellness™

COMPARE TO THE ACTIVE INGREDIENTS OF VICKS® DAYQUIL® LIQUICAPS®*

Non-Drowsy
Daytime Multi-Symptom
Cold & Flu Relief
Acetaminophen,
Dextromethorphan HBr,
Phenylephrine HCl

For Relief of:
Aches, Fever, Sore Throat, Cough, Nasal Congestion

16 LIQUID CAPS

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® Liquicaps®.
Product of Canada    50844    REV0113B53421
DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.
10401 MONROE RD, MATTHEWS, NC 28105 USA
Not 100% satisfied? Return package and unused product within 30 days to any Family Dollar store for a refund (with reciept) or exchange.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Principal display panel
Family Wellness 44-534

Non-Drowsy Daytime Multi-Symptom Cold and Flu

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55319-534
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
sorbitol
FD&C YELLOW NO. 6
FD&C RED NO. 40
water

Product Characteristics

Color Size Imprint Code Shape
ORANGE 21 mm 95A CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 NDC:55319-534-21 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-09-19


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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