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

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Nighttime Cold and Flu

Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

NIGHTTIME COLD AND FLU capsule, liquid filled


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine Succinate 6.25 mg

Purpose

Pain reliever/ fever reducer

Cough suppressant 

Antihistamine

Nighttime Cold and Flu Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches/pains
  • fever
  • runny nose & 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
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Sore throat warning: If sore throat is severe, persists 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 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 sleep                                                                                                         

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • cough with excessive phlegm(mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • difficulty in 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

  • do not exceed the recommended dosage
  • do not use for more than 7 days
  • excitability may occur especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and Ask a doctor if

  • you get nervous, dizzy, or sleepless
  • swelling or redness is present
  • symptoms do not get better or are accompanied by a fever that lasts more than 3 days or if new symptoms occur
  • cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache.

These may 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) could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

  • take only as directed - see overdose warning
  • do not exceed 4 doses per 24 hours

Adults and children 12 years of age and over

 Swallow 2 softgels with water every 6 hours

Children 4 to 12 years of age

 ask a doctor

children under4 years o9f age

do not use

If taking NIGHTTIME and DAYTIME softgels carefully read each label to insure correct dosing.

Nighttime Cold and Flu Other information

  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • this product does not contain phenylpropanolamine (PPA)

Inactive ingredients

D&C Yellow # 10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

PRINCIPAL DISPLAY PANEL - Shipping Label

NIGHTTIME COLD AND FLU CAPSULES

Quantity : 4000 Capsules
NDC. No : 53345-006-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

Nighttime Cold and Flu

Nighttime Cold and Flu

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53345-006
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
povidone
propylene glycol
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
green 21 mm PC10 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 4000 in 1 BAG
2 NDC:53345-006-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-04-15


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