NDC | 66715-6934-4 |
Set ID | 57c458ed-7987-453b-ab24-bbfa6580f920 |
Category | HUMAN OTC DRUG LABEL |
Packager | Lil' Drug Store Products, Inc |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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.
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.
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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
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
QUALITY
⋆ GUARANTEED ⋆Compare to the Active Ingredients
in Vicks® NyQuil®*10% Alcohol
Cherry
Cold & Flu
NighttimeAcetaminophen 650 mg, Pain Reliever/Fever Reducer
Dextromethorphan HBr 30 mg, Cough Suppressant
Doxylamine Succinate 12.5 mg, AntihistamineRelieves
• Aches • Sore Throat • Fever
• Runny Nose • Sneezing • Cough8 FL OZ
(237 mL)Lil'
Drug Store® -
INGREDIENTS AND APPEARANCE
NIGHTTIME COLD AND FLU LIL DRUG STORE PRODUCTS
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquidProduct 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)