dg health cough and sore throat description, usages, side effects, indications, overdosage, supplying and lots more!

dg health cough and sore throat

Dolgencorp Inc

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Dolgencorp, LLC Cold & Cough Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

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)
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
adults & children 12 years & over
  • take 2 tablespoons (TBSP) in dose cup provided every 6 hours
  • do not take more than 6 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 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

Nite Time

Cold & Cough

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

Pain Reliever, Cough Suppressant, Antihistamine

Compare to active ingredients in Tylenol® Cold & Cough

SEE NEW WARNINGS AND DIRECTIONS

INSTANT COOLING SENSATION

Cool Ice®

Principal Display Panel
Cold & Cough Front Label Image Cold & Cough Back Label Image

dg health cough and sore throat

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55910-666
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
CARBOXYMETHYLCELLULOSE SODIUM
FD&C BLUE NO. 1
POLYETHYLENE GLYCOLS
propylene glycol
water
SODIUM BENZOATE
sorbitol
SUCROSE

Product Characteristics

Color
BLUE (clear)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55910-666-34 237 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-02-06


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Be sure to consult your doctor before taking any medication!
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