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

Nite-Time

Salado Sales, Inc.
AptaPharma Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

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.

Uses

 temporarily relieves cold/flu symptoms:

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

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.

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

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 Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours
Directions


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

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

Product Label

Compare to VICKS® NYQUIL® active ingredients    CVP CONSUMER VALUE PRODUCTS

Nite-Time COLD/FLU Medicine

Multi-Symptom ORIGINAL FLAVOR

Acetaminophen ..........................Aches, Fever and Sore Throat

Dextromethorphan ......................Cough

Doxylamine Succinate ................Sneezing, Runny nose

6 FL OZ (177 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN


*This product is not manufactured or distributed by Proctor and Gamble, distributor of Vicks® Nyquil®   LR-002

Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944

Distributed by: Salado Sales, Inc. P.O. Box 6115 Temple, TX 76503   www.saladosales.com

LOT:        EXP:

Peel Here  DRUG FACTS CONTINUED ON BACK

ORIGINAL FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine

> Antihistamine

> Cough Suppressant

>Pain Reliever

>Fever Reducer


Product Label

Product Label


Nite-Time

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57243-501
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
water
SACCHARIN SODIUM DIHYDRATE
SODIUM BENZOATE
SODIUM CITRATE
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57243-501-25 177 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-01-16


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Be sure to consult your doctor before taking any medication!
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