NDC | 53943-501-28 |
Set ID | e243033b-6603-4c3e-a330-e7c7de51f69d |
Category | HUMAN OTC DRUG LABEL |
Packager | Discount Drug Mart |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- Drug FactsActive ingredients (in each 30 mL dose cup)
- Purpose
- Keep out of reach of children
- Uses
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WARNINGS
DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage
may occur if adult/child takes: ● more than 4 doses in 24 hours, which is
the maximum daily amount for this product ● with other drugs containing
acetaminophen ● 3 or more alcoholic drinks everyday while using this product.
Allery Alert: Acetaminophen may cause severe skin reactions.
Symptoms may include: ● skin reddening ● blisters ● rash
If 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
- 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 monamine 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
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use
- When using this product
-
Stop use and ask a doctor if
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by a fever
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
- If pregnant or breast-feeding,
- Overdose warning:
-
Directions
- take only as recommended-see Overdose warning
- Use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
- if taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours.
adults and children 12 years and over 30 mL (2 TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use - Other information
- Inactive ingredients
- Questions?
-
DISCOUNT drug mart FOOD FAIR Original Night-Time Multi-Symptom Cold/Flu Relief product label
*COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL®
DISCOUNT
drug mart
FOOD FAIR
Original
Night-Time Multi-Symptom Cold/Flu Relief
Acetaminophen ...... Pain Reliever/Fever Reducer
Dextromethorphan HBR ....... Cough Suppressant
Doxylamine Succinate ........... Antihistamine
12 FL OZ (354 mL)
* This product is not manufactured or distributed by Proctor and Gamble owner of the registered trademark Vicks® Nyquil®
LR-065 REV 01
SATISFACTION GUARANTEED
IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256
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INGREDIENTS AND APPEARANCE
ORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-501 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-501-28 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/21/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/21/2014 Labeler - Discount Drug Mart (047741335)