Nighttime Cold And Flu
FDA Label NDC 70005-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product Nighttime Cold And Flu (NDC 70005-005). 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 other, otc - purpose, uses, liver warning:, sore throat warning:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

 
 Active Ingredient (in each softgel) Purpose
 Acetaminophen 325 mg Pain reliever/fever reducer
 Dextromethorphan HBr 15 mg

Cough suppressant

Doxylamine succinate 6.25 mg

Antihistamine

 

Uses

Temporarily relieves common cold/flu symptoms:

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

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 monomine 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
  • gloucoma
  • 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
  • cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are

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

When Using This Product

  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • may cause marked 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
  • new symptoms occur
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts

    • These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 directed - see Liver warning

  • do not exceed 8 softgels per 24 hours

  • adults and children 12 years and over: 2 softgels with water every 6 hours

  • children 4 to under 12 years: ask a doctor

  • children under 4 years: do not use

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

Other Information

  • store at 20°-25°C (68°-77°F)

  • read all product information before using. Keep this box for important information

Inactive Ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, purified water, sorbitol special, sorbitol solution, titanium dioxide

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Compare to the Active Ingredients in

NyQuil® LiquiCaps®


Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate 325 mg, 15 mg and 6.25 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Softgels Each

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