Daytime Cold and Flu Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Daytime Cold and Flu Relief

A&Z Pharmaceutical, Inc.
A&Z Pharmaceutical, Inc.

Daytime Cold and Flu relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS (IN EACH SOFTGEL)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCI 5mg

PURPOSES

Pain reliever/fever reducer

Cough suppressant

Antihistamine

USES

temporarily relieves common cold and fly symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • 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 for this product
  • 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 or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • with any other product 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 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 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 last 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 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: In case of accidental overdose, contact a doctor or Poison Control Center immediately (1-800-222-1222). Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

DIRECTIONS

  • take only as directed (see Warnings)
  • do not exceed 4 doses per 24 hours

Adults and children 12 years and over

  • 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 is torn or open

INACTIVE INGREDIENTS

FD&C Red #40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol. May also contain FD&C Yellow #6, titanium dioxide.

QUESTIONS OR COMMENTS?

Call toll free 1-888-952-0050

PRINCIPAL DISPLAY PANEL

Product Label

*Compare to active ingredients in Vicks® Dayquil® Cold & Flu LiquiCaps

*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® Dayquil® Cold & Flu Liquicaps

Acetaminophen/Dextromethrophan HBr/Phenylephrine HCI

  • Aches
  • Fever
  • Sore Throat
  • Sneezing
  • Runny Nose
  • Cough

Manufactured for:

A & Z Pharmaceutical, Inc.

Hauppauge, NY 11788

Daytime Cold and Flu Relief

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62211-339
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
GELATIN
GLYCERIN
FD&C RED NO. 40
polyethylene glycol 400
povidone
propylene glycol
water
sorbitol
FD&C YELLOW NO. 6
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
orange (amber) 20 mm 534 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 20 in 1 BLISTER PACK
3 NDC:62211-339-51 2 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-06-09


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