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Nighttime Cold and Flu Lil Drug Store Products

Medically reviewed on November 20, 2017

Dosage form: liquid
Ingredients: Acetaminophen 650mg in 30mL, Dextromethorphan Hydrobromide 30mg in 30mL, Doxylamine Succinate 12.5mg in 30mL
Labeler: Lil' Drug Store Products, Inc
NDC Code: 66715-6934

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Lil' Drug Store® Nighttime Cold & Flu

Drug Facts

Active ingredients (in each 30 mL)Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 30 mgCough suppressant
Doxylamine succinate 12.5 mgAntihistamine

Uses
  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • runny nose and sneezing
    • fever
    • cough due to minor throat and bronchial irritation

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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
  • 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.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have
  • liver disease
  • glaucoma
  • a sodium-restricted diet
  • 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 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
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if
  • pain or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts. These could 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) may cause liver damage. 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
  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measure only with the dosing cup provided. Do not use any other dosing device.
  • mL = milliliter
  • keep dosing cup with product
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 years of age: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information
  • each 30 mL contains: potassium 10 mg
  • each 30 mL contains: sodium 38 mg
  • store between 68-77°F (20-25°C). Do not refrigerate.

Inactive ingredients

acesulfame potassium, alcohol, citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

QUALITY GUARANTEED

Compare to the Active Ingredients
in Vicks® NyQuil®*

10% Alcohol

Cherry

Cold & Flu
Nighttime

Acetaminophen 650 mg, Pain Reliever/Fever Reducer
Dextromethorphan HBr 30 mg, Cough Suppressant
Doxylamine Succinate 12.5 mg, Antihistamine

Relieves
• Aches • Sore Throat • Fever
• Runny Nose • Sneezing • Cough

8 FL OZ
(237 mL)

Lil'
Drug Store®

NIGHTTIME COLD AND FLU   LIL DRUG STORE PRODUCTS
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6934(NDC:49580-0343)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen650 mg  in 30 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide30 mg  in 30 mL
Doxylamine Succinate (Doxylamine) Doxylamine Succinate12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Acesulfame Potassium 
Alcohol 
Citric Acid Monohydrate 
FD&C blue NO. 1 
FD&C red NO. 40 
High Fructose Corn Syrup 
Polyethylene Glycol, Unspecified 
Propylene Glycol 
Water 
Saccharin Sodium 
Sodium Citrate, Unspecified Form 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:66715-6934-4237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/01/2014
Labeler - Lil' Drug Store Products, Inc (093103646)

 
Lil' Drug Store Products, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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