NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Nite-TimeCOLD/FLU CHERRY by

Drug Labeling and Warnings

Nite-TimeCOLD/FLU CHERRY 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 4,000 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 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 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

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

These could be signs of a serious condition.

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

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

• 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, FD and C Blue No. 1, FD&C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Nite Time Cherry product label

Compare to VICKS® NYQUIL® active ingredients   

CVP® CONSUMER VALUE PRODUCTS

Nite-Time COLD/FLU Medicine

Multi-Symptom CHERRY FLAVOR

Acetaminophen Aches, Fever & 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-003

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

LR-003 Rev 02

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

LOT:        EXP:

Peel Here  DRUG FACTS CONTINUED ON BACK

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

• Antihistamine
• Cough Suppressant
• Pain Reliever
• Fever Reducer

INGREDIENTS AND APPEARANCE

NITE-TIMECOLD/FLU CHERRY  COLD/FLU CHERRY
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57243-502
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
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)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (CHERRY FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57243-502-25	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/31/2012

Labeler - Salado Sales, Inc. (009830555)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(57243-502)