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  5. Label Information: Nighttime Cold And Flu Lil Drug Store Products

FDA Label for Nighttime Cold And Flu Lil Drug Store Products

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    5. ALLERGY ALERT
    6. SORE THROAT WARNING
    7. DO NOT USE
    8. ASK A DOCTOR BEFORE USE IF YOU HAVE
    9. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    10. WHEN USING THIS PRODUCT
    11. STOP USE AND ASK A DOCTOR IF
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. OVERDOSE WARNING
    15. DIRECTIONS
    16. OTHER INFORMATION
    17. INACTIVE INGREDIENTS
    18. QUESTIONS OR COMMENTS?
    19. PRINCIPAL DISPLAY PANEL - 237 ML BOTTLE LABEL

Nighttime Cold And Flu Lil Drug Store Products Product Label

The following document was submitted to the FDA by the labeler of this product Lil' Drug Store Products, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



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

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.

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.


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®


* Please review the disclaimer below.