healthy accents cough and sore throat night time

Dosage form: liquid
Ingredients: ACETAMINOPHEN 500mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL
Labeler: DZA Brands LLC
NDC Code: 55316-666

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.

DZA Brands, LLC Cough & Sore Throat 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:
headache
cough
runny nose and sneezing
sore throat
minor aches and pains

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 4 doses 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.

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

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

When using this product
marked drowsiness may occur
avoid alcoholic drinks
excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase drowsiness
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.

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 Liver warning)

adults and children 12 years and over

take 2 tablespoons (TBSP) in dose cup provided every 6 hours as needed
do not take more than 8 tablespoons in 24 hours

children under 12 years

do not use this adult product in children under 12 years of age

Other information
each tablespoon contains: potassium 20 mg and sodium 8 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose

Questions or comments?

1-866-322-2439

Principal Display Panel

Compare to Tylenol® Cough & Sore Throat active ingredients

nighttime

cough & sore throat

pain reliever – cough suppressant – antihistamine

sore throat, body aches/headache (acetaminophen)

coughing (dextromethorphan HBr)

runny nose (doxylamine succinate)

Cool Ice® instant cooling sensation

8 FL OZ (237 mL)

HEALTHY ACCENTS COUGH AND SORE THROAT  NIGHT TIME
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-666
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:55316-666-34237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/24/2008
Labeler - DZA Brands LLC (090322194)

Revised: 03/2014
 
DZA Brands 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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