NIGHTTIME COLD AND FLU LIL DRUG STORE PRODUCTS- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquid

Nighttime Cold and Flu by

Drug Labeling and Warnings

Nighttime Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 30 mL)	Purposes
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 30 mg	Cough suppressant
Doxylamine succinate 12.5 mg	Antihistamine

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
• 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 4 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 5 mg
• each 30 mL contains: sodium 24 mg
• store between 20-25°C (68-77°F). 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®

INGREDIENTS AND APPEARANCE

NIGHTTIME COLD AND FLU   LIL DRUG STORE PRODUCTS
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-6934
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	650 mg  in 30 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	30 mg  in 30 mL
Doxylamine Succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL)	Doxylamine Succinate	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Acesulfame Potassium (UNII: 23OV73Q5G9)
Alcohol (UNII: 3K9958V90M)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
FD&C blue NO. 1 (UNII: H3R47K3TBD)
FD&C red NO. 40 (UNII: WZB9127XOA)
High Fructose Corn Syrup (UNII: XY6UN3QB6S)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-6934-4	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/01/2014

Labeler - Lil' Drug Store Products, Inc (093103646)