Night Time
FDA Label NDC 68016-135

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Night Time (NDC 68016-135). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, keep out of reach of children, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Drug Facts

Active ingredients (in each tablespoonful, 15 mL)

Acetaminophen 325 mg   
Dextromethorphan HBr 15 mg   
Doxylamine Succinate 6.25 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:

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


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 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

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

Ask A Doctor Or Pharmacist Before Use

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


When Using This Product

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


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, or persistent headache.

    • 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 (overdose) may cause liver damage. 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 warning)
  • use dose cup or tablespoon (TBSP)
  • do not take more than 4 doses in any 24-hours
    • Aptapharmapv Nighttimemsch2 Label (Aptapharmapv Nighttimemsch2)

    Aptapharmapv Nighttimemsch2 Label (Aptapharmapv Nighttimemsch2)


Other Information

  • each tablespoonful (15 mL) contains: sodium 23 mg
  • dosage cup provided
  • store between 20-25° C (68-77° F)
  • do not refrigerate
  • Keep carton for full directions for use

Inactive Ingredients

anhydrous citric acid, FD and C Blue No. 1, FD and C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Product Label

NDC 68016-135-00
COMPARE TO THE ACTIVE INGREDIENTS IN DELSYM® NIGHT TIME MULTI-SYMPTOM

Premier Value®

Night Time
MULTI-SYMPTOM COLD/FLU RELIEF

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

Cough
Fever and Body Aches
Sore Throat
Sneezing and Runny Nose
Cherry Flavored Liquid

For Ages 12 +

4 FL OZ (120 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 Reckitt Benckiser Inc.,Distributor of Delsym® Night Time Multi-Symptom

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
BX-007

Aptapharmapv Nighttimemsch Label (Aptapharmapv Nighttimemsch)

Aptapharmapv Nighttimemsch Label (Aptapharmapv Nighttimemsch)

* Please review the disclaimer below.