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Name:Night Time Cough And Sore Throat Cool Blast
Manufacturer:Cvs
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

NIGHT TIME COUGH AND SORE THROAT COOL BLAST  - acetaminophen, dextromethorphan hydrobromide and doxylamine succinate syrup 
CVS

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

in each 30ml, 2 tablespoon,

Acetaminophen 1000 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg

Purposes

Acetaminophen...........................................Pain reliever/fever reducer
Dextromethorphan HBr.....................................................Cough suppressant
Doxylamine succinate...............................................................Antihistamine

Uses

temporarily relieves • minor aches and pains
• headaches • coughs • sore throat • runny nose and sneezing

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur
if you take: • more than 4 doses (8 tablespoonfuls or 120 mL) in 24 hours, which is the
maximum daily amount • with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday while using this product
Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high
fever, headache, rash, nausea, and vomiting may be serious. Ask a doctor right away.
Do not use more than 2 days or give to children under 12 years of age unless directed
by a doctor.

Do Not Use

• to make a child sleepy • if you are on a sodium-restricted diet
• 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 two
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.
• with any other drug containing acetaminophen (prescription or non-prescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

• glaucoma • liver disease
• cough that occurs with too much phlegm (mucus)
• breathing problems such as emphysema or chronic bronchitis
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking

• sedatives or tranquilizers • the blood thinning drug warfarin

When using this product

• do not exceed recommended dosage
(see overdose warning)
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers
may increase drowsiness
• be careful when driving a motor
vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

• pain or cough gets worse or lasts for more than 7 days
• fever gets worse or lasts for more than 3 days
• new symptoms occur
• redness or swelling is present
• 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 this and all drugs out of the reach of children.

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Quick medical attention is critical for adults as well as for children even if you do not notice any
signs or symptoms.

Directions

• do not take more than directed (see overdose warning)

age                                                                            dose
adults and children 12 years and over................take 2 tablespoons (tbsps) in dose cup provided every 6 hours as needed
children under 12 years.......................do not use this adult product in children under 12 years of age; this will provide more                                                              than the recommended dose (overdose) and may cause liver damage

Other Information

• store at controlled room temperature
• dosage cup provided

Inactive Ingredients

acesulfame potassium, blue 1, carboxymethylcellulose sodium, citric acid,
flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

Principal Display Panel

CVS Pharmacy
compare to the active ingredients in tylenol cough and sore throat
Cough and sore throat nighttime
pain reliever, cough suppressant, antihistamine
Instant cooling liquid sensation
Sore throat, body aches, headache-Acetaminophen
coughing-Dextromethorphan HBr
Runny nose-Doxylamine succinate
8 fl oz 237mL
image of label


NIGHT TIME COUGH AND SORE THROAT COOL BLAST 
tylenol cough and sore throat syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-666
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 1000 mg  in 30 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 30 mg  in 30 mL
Doxylamine Succinate (Doxylamine) Doxylamine Succinate 12.5 mg  in 30 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM  
FD&C BLUE NO. 1  
CARBOXYMETHYLCELLULOSE SODIUM  
CITRIC ACID MONOHYDRATE  
POLYETHYLENE GLYCOL  
PROPYLENE GLYCOL  
WATER  
SODIUM BENZOATE  
SORBITOL  
SUCROSE  
Product Characteristics
Color      Score     
Shape Size
Flavor ANISE (Nyquil Original Flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-666-34 237 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/08/2009

Labeler - CVS (062312574)
Registrant - Aaron Industries, Inc. (101896231)
Establishment
Name Address ID/FEI Operations
Aaron Industries, Inc. 101896231 manufacture, analysis

Revised: 05/2010 CVS



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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