Night-Time Original description, usages, side effects, indications, overdosage, supplying and lots more!

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Night-Time Original

Chain Drug Consortium, LLC
AptaPharma Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Drug Facts

Active ingredients (in each 30 mL dose cup)


Acetaminophen 650 mg   

Dextromethorphan HBr 30 mg   

Doxylamine Succinate 12.5 mg

Purpose

Pain reliever/fever reducer   
Cough suppressant   
Antihistamine  

Keep out of reach of children

Keep out of reach of children.

Night-Time Original Uses

temporarily relieves cold/flu symptoms:

  • sore throat
  • headache   
  • minor aches and pain
  • fever
  • runny nose and sneezing
  • cough due to minor sore throat and bronchial irritation

 

Warnings

Failure to follow these warnings could result in serious consequences

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 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 sleepy

Ask a doctor before use if you have

  • a sodium restricted diet
  • 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 or pharmacist before use

  • if you are taking sedatives or tranquilizers
  • if you are taking the blood thinning drug warfarin

When using this product

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

Stop use and ask a doctor if

  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts


  • These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before use.

Overdose warning

 Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center 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

  • take only as recommended-see Overdose warnings
  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
  • If taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours
Night-Time Original

Night-Time Original Other information

  • each 30 mL dose cup contains:
  • sodium 45 mg
  • store at room temperature

Inactive ingredients

citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Questions?

Call weekdays

1-877-798-5944

Product Label

NDC 68016-144-01
COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL®

Premier Value®

Original

Night-Time
MULTI-SYMPTOM COLD/FLU RELIEF

Acetaminophen……Pain Reliever/Fever Reducer
Dextromethorphan HBr……Cough Suppressant
Doxylamine Succinate ……………Antihistamine

12 FL OZ (354 mL)
INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by Procter and Gamble, owner of the registered trademark Vicks® NyQuil®

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

DISTRIBUTED BY
CHAN DRUG CONSORTIUM
3301 NW BOCO RATON BLVD
SUITE 101, BOCA RATON FL 33431
LR-024

Night-Time Original

Night-Time Original

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-144
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 30 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 12.5 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
D&C YELLOW NO. 10
FD&C GREEN NO. 3
FD&C YELLOW NO. 6
GLYCERIN
polyethylene glycol 400
propylene glycol
water
saccharin sodium
SODIUM BENZOATE
SODIUM CITRATE
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68016-144-00 236 in 1 BOTTLE
2 NDC:68016-144-01 354 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-09-01


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