NITE TIME COLD FLU RELIEF- acetaminophen,dextromethorphan hbr, doxylamine succinate liquid

nite time by

Drug Labeling and Warnings

nite time by is a Otc medication manufactured, distributed, or labeled by We Care Distributor Inc., PURINE PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves 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. The maximum daily dose of this product is 4 doses. Severe liver damage may occur if adult/child takes:

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than two 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 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.
• if you have ever had an allergic reaction to this product or any of its ingredients
• to make a child sleepy

Ask a doctor before use if you have

• liver disease
• glaucoma
• a sodium-restricted diet
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or occurs with smoking, asthma chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• do not use more than directed
• 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

• redness or swelling is present
• pain or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• 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 recommended dose may cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as directed. (see overdose warning)
• use dose cup
• do not exceed 4 doses per 24 hours

• adults and children 12 years and over: 30 mL every 6 hours
• children 4 to under 12 years: ask a doctor
• children under 4 years: do not use

• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information

• each 15 mL (tablespoon) contains: sodium 46 mg
• store at 15°-30°C (59°-86°F)
• protect from freezing

Inactive ingredients

alcohol, citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sodium benzoate

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel

See New Warnings Information

Compare to NyQuil® Cold & Flu Active Ingredients

NiteTime

Cold & Flu

Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

Multi-Symptom Relief

Aches, Fever - Acetaminophen

Cough - Dextromethorphan HBr

Sneezing, Runny Nose - Doxylamine Succinate

Original Flavor

10% Alcohol

INGREDIENTS AND APPEARANCE

NITE TIME  COLD FLU RELIEF
acetaminophen,dextromethorphan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70005-046
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 15 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
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)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	GREEN (Bright)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70005-046-01	1 in 1 CARTON	08/10/2016
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/10/2016

Labeler - We Care Distributor Inc. (079832998)

Establishment
Name	Address	ID/FEI	Business Operations
PURINE PHARMA LLC		019950491	manufacture(70005-046)