healthy accents nighttime cold and flu description, usages, side effects, indications, overdosage, supplying and lots more!

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healthy accents nighttime cold and flu

DZA Brands LLC

DZA Brands, LLC Nighttime Cold & Flu Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

healthy accents nighttime cold and flu Uses

temporarily relieves common cold/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. The maximum daily dose of this product is 8 softgels (2,600 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

  • •more than 4,000 mg of acetaminophen in 24 hours
  • •with other drugs containing acetaminophen
  • •3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • •to make a child sleepy
  • •if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

  • •taking sedatives or tranquilizers
  • •taking the blood thinning drug warfarin

When using this product

  • •excitability may occur, especially in children
  • •may cause marked drowsiness
  • •avoid alcoholic drinks
  • •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 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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 Liver warning
  • •do not exceed 8 softgels per 24 hours

adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

  • •when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Inactive Ingredients

D&C yellow no. 10, edible ink, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-866-322-2439

Package/Label Principal Display Panel

Compare to Vicks® NyQuil® Cold & Flu active ingredients

nighttime

cold & flu

pain reliever – fever reducer

cough suppressant – antihistamine

aches, fever, sore throat (acetaminophen)

cough (dextromethorphan HBr)

sneezing, runny nose (doxylamine succinate)

24 softgels

alcohol free

gluten free

healthy accents nighttime cold and flu

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55316-056
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
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
POVIDONES
propylene glycol
water

Product Characteristics

Color Size Imprint Code Shape
GREEN (clear) 20 mm 056 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2 in 1 BLISTER PACK
2 NDC:55316-056-62 12 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-02-13


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Be sure to consult your doctor before taking any medication!
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