ORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Original Night-Time by

Drug Labeling and Warnings

Original Night-Time by is a Otc medication manufactured, distributed, or labeled by Discount Drug Mart. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive ingredients (in each 30 mL dose cup)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Keep out of reach of children

Keep out of reach of children.

Uses

temporarily relieves cold/flu symptoms

• sore throat
• headache
• minor aches and pain
• fever
• runny nose and sneezing
• cough due to minor throat and bronchial irritation

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

• a sodium restricted diet
• 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 enlarged prostate gland.

Ask a doctor or pharmacist before use

• if you are taking sedatives or tranquilizers
• if you are taking the blood thinning drug warfarin

When using this product

• do not use more than directed
• avoid alcoholic drinks
• excitability may occur, especially in children
• marked drowsiness may occur
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and tranquilizers may increase drowsiness

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,

ask a health professional before use.

Overdose warning:

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help, or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms

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

• each 30 mL dose cup contains: sodium 45 mg
• store at room temperature

Inactive ingredients

citric acid, D and C yellow # 10, FD and C Green No. 3, FD and C Yellow No. 6,  flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Questions?

Call weekdays 1-877-798-5944

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

INGREDIENTS AND APPEARANCE

ORIGINAL NIGHT-TIME  MULTI-SYMPTOM COLD/FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Product 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 GLYCOLS (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)