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

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Nighttime Cold and Flu Relief

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

Nighttime Cold and Flu Relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS (IN EACH SOFTGEL)

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

PURPOSES

Pain reliever/fever reducer

Cough suppressant

Antihistamine

USES

temporarily relieves common cold and flu symptoms:

  • Cough due to minor throat and bronchial irritation
  • Sore throat
  • headache
  • minor aches and pains
  • fever, runny nose and sneezing

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 drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • Liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor/pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drink
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • fever get worse or last 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 of symptoms

DIRECTIONS

  • do not take more than directed (see Warnings)
  • do not exceed 4 doses per 24 hours

Adults and children 12 years and over:

  • take 2 softgels with water every 6 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 Green #3, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol. May also contain FD&C Blue #1, D&C Yellow #10, titanium dioxide.

QUESTIONS OR COMMENTS?

Call toll free 1-888-952-0050

PRINCIPAL DISPLAY PANEL

Product Label

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

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

Acetaminophen/Dextromethorphan/Doxylamine

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

Manufactured for:

A&Z Pharmaceutical, Inc

Hauppauge, NY 11788

Nighttime Cold and Flu Relief

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62211-340
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 mg

Inactive Ingredients

Ingredient Name Strength
FD&C GREEN NO. 3
GELATIN
GLYCERIN
polyethylene glycol 400
povidone
propylene glycol
sorbitol
water
titanium dioxide
FD&C BLUE NO. 1
D&C YELLOW NO. 10

Product Characteristics

Color Size Imprint Code Shape
green 20 mm 535 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62211-340-09 10 in 1 BLISTER PACK
2 NDC:62211-340-51 20 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2011-03-25


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