NITE-TIME COLD/FLU MEDICINE- acetaminophen liquid

Nite-Time by

Drug Labeling and Warnings

Nite-Time by is a Otc medication manufactured, distributed, or labeled by AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Drug Facts

Active ingredients (in each 30 mL dose cup)

Acetaminophen 650 mg   Dextromethorphan HBr 30 mg   Doxylamine Succinate 12.5 mg 

Purpose

Purpose

Pain reliever/fever reducer   Cough suppressant   Antihistamine 

Keep Out Of Reach Of Children

Keep out of reach of children.

Uses

Uses temporarily relieves cold/flu symptoms:

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

Warnings

Failure to follow these warnings could result in serious consequences

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take * more than 4 doses in 24 hours, which is the maximum daily amount *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 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask A Doctor

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

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

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

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, headache that lasts
  

Pregnant Or Breast-Feeding

If pregnant or breast-feeding, ask a health professional before use.

Overdose Warning

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 for children even if you do not notice any signs or symptoms.

Directions

Directions

• take only as recommended-see Overdose warnings
• Use dose cup or tablespoon (TBSP)
• do not exceed 4 doses per 24 hours

adults and children 12 years and over                     30 mL (2TBSP) every 6 hours
children 4 to under 12 years                                   ask a doctor
children under 4 years                                            do not use

• If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours

Other Information

Other information

• each 30 mL dose cup contains:

• sodium 45 mg
• store at room temperature
  

Inactive Ingredients

Inactive ingredients: citric acid, D and C yellow No. 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

Do Not Use

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
• to make a child sleepy
  

Package Label - Night Time Cold & Flu Relief

NDC: 76281-501-28

AP SAFE

*COMPARE TO
the active ingredients in
VICKS® NYQUIL®

Night Time

Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Doxylamine Succinate – Antihistamine

Multi-Symptom
Cold & Flu Relief

Original Flavor

12 FL OZ (354 mL)

DO NOTUSE IF IMPRINTEDSHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences

Drug Facts

Active Ingredients (in each 30 mL dose cup)                        Purpose
Acetaminophen 650 mg………………………………........Pain reliever/fever reducer
Dextromethorphan HBr 30 mg………………………….…Cough suppressant
Doxylamine Succinate 12.5 mg……………………………..Antihistamine

Usestemporarily relieves cold/flu symptoms: ■ sore throat ■ headache
■ minor aches and pains ■ fever ■ runny nose and sneezing
■ 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 4,000 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 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 ■ for more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor. ■ 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 a 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 prostrate 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 ►

Drug Facts (continued)

■ 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.
Keep out of reach of children.

Overdose Warning: Taking more than the recommended dose (overdose) may
cause liver damage. In case of accidental 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 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 & 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 Made in USA
contains: sodium 45 mg ■ store at room temperature AP-LR-08

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

Questions? Call weekdays 1-877-798-5944

*This product is not manufactured or distributed by Procter &
Gamble, owner of the registered trademark Vicks® NyQuil®.
Manufactured by: AptaPharma Inc.,
1533 Union Ave., Pennsauken, NJ 08110

INGREDIENTS AND APPEARANCE

NITE-TIME  COLD/FLU MEDICINE
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-501
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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 400 (UNII: B697894SGQ)
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: 76281-501-28	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/09/2018

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-501)