dg health cough and sore throat nite time

Dosage form: solution
Ingredients: ACETAMINOPHEN 500mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL
Labeler: Dolgencorp, LLC
NDC Code: 55910-666

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.

Dolgencorp, LLC Cold & Cough Drug Facts

Active ingredients (in each 15 mL = 1 tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever

Cough suppressant

Antihistamine

Uses
temporarily relieves the following cold/flu symptoms:
minor aches and pains
headache
sore throat
runny nose and sneezing
cough

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoons (3,000 mg acetaminophen) in 24 hours. 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

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.
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
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product
excitability may occur, especially in children
may cause marked drowsiness
alcohol, sedatives and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
pain or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
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 the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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)
use only enclosed dosing cup designed for this product. Do not use any other dosing device.

adults & children 12 years & over

take 30 mL (2 TBSP) in dose cup provided every 6 hours
do not take more than 6 tablespoons in 24 hours

children under 12 years

ask a doctor

Other information
each tablespoon contains: potassium 25 mg and sodium 8 mg
store between 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue #1, flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose

Questions or comments?

1-888-309-9030

Principal Display Panel

Night Time

Cold & Cough

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

Pain Reliever, Cough Suppressant, Antihistamine

Compare to active ingredients in Tylenol® Cold & Cough

INSTANT COOLING SENSATION

Cool Ice®

8 FL OZ (237 mL)

DG HEALTH COUGH AND SORE THROAT  NITE TIME
acetaminophen, dextromethorphan hbr, doxylamine succinate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-666
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
CARBOXYMETHYLCELLULOSE SODIUM 
FD&C BLUE NO. 1 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
Product Characteristics
ColorBLUE (clear) Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55910-666-34237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/06/2010
Labeler - Dolgencorp, LLC (068331990)

Revised: 08/2014
 
Dolgencorp, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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