NITE-TIME COLD/FLU ORIGINAL- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Nite-Time by

Drug Labeling and Warnings

Nite-Time by is a Otc medication manufactured, distributed, or labeled by Salado Sales, Inc., AptaPharma Inc.. 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
• 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

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 amoun
  
  • 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 ccurs, 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.

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, headache that lasts

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

Directions

• take only as recommended-see Overdose warnings
• Use dose cup or tablespoon (TBSP)
• do not exceed 4 doses per 24 hours
• If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours

Other Information

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

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

• 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

Product Label

Compare to VICKS® NYQUIL® active ingredients    CVP CONSUMER VALUE PRODUCTS

Nite-Time COLD/FLU Medicine

Multi-Symptom ORIGINAL FLAVOR

Acetaminophen ..........................Aches, Fever and Sore Throat

Dextromethorphan ......................Cough

Doxylamine Succinate ................Sneezing, Runny nose

6 FL OZ (177 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Proctor and Gamble, distributor of Vicks® Nyquil®   LR-002

Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944

Distributed by: Salado Sales, Inc. P.O. Box 6115 Temple, TX 76503   www.saladosales.com

LOT:        EXP:

Peel Here  DRUG FACTS CONTINUED ON BACK

ORIGINAL FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine

•  Antihistamine

• Cough Suppressant

• Pain Reliever

• Fever Reducer

INGREDIENTS AND APPEARANCE

NITE-TIME  COLD/FLU ORIGINAL
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57243-501
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)
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: 57243-501-25	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/16/2012

Labeler - Salado Sales, Inc. (009830555)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(57243-501)