cold relief description, usages, side effects, indications, overdosage, supplying and lots more!

cold relief

Publix Super Markets 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
Publix Super Markets, Inc. Cold Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet) (Nighttime)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose (Nighttime)

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses (Nighttime)

  • temporarily relieves these common cold symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough
  • sneezing and runny nose
  • helps clear nasal passages
  • relieves cough to help you sleep
  • temporarily reduces fever

Warnings (Nighttime)

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

  • more than 12 caplets in 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • 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

  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion 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 (Nighttime)

  • do not take more than directed (see Liver warning)
  • do not take the Day and Night caplets at the same time
  • do not take more than a total of 12 caplets in 24 hours
adults and children 12 years and over
  • take 2 caplets every 4-6 hours
  • swallow whole – do not crush, chew or dissolve
children under 12 years

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

Inactive ingredients (Nighttime)

acesulfame potassium, blue no. 1 lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide

Active ingredient (in each caplet) (Daytime)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose (Daytime)

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses (Daytime)

  • temporarily relieves these common cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough
  • sinus congestion and pressure
  • helps clear nasal passages
  • promotes nasal and sinus drainage
  • temporarily reduces fever

Warnings (Daytime)

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

  • more than 12 caplets in 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.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that lasts or is chronic 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

When using this product

do not use more than directed

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion 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.

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 (Daytime)

  • do not take more than directed (see Liver warning)
  • do not take the Day and Night caplets at the same time
  • do not take more than a total of 12 caplets in 24 hours

     

adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole – do not crush, chew or dissolve
children under 12 years

do not use this adult product in children under

12 years of age

Inactive ingredients (Daytime)

acesulfame potassium, carnauba wax, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide

Principal Display Panel

SEE NEW WARNINGS INFORMATION

MULTI SYMPTOM

coldrelief

PAIN RELIEVER/FEVER REDUCER, NASAL DECONGESTANT

COUGH SUPPRESSANT, ANTIHISTAMINE†

DAYTIME

ACETAMINOPHEN

DEXTROMETHORPHAN HBr

PHENYLEPHRINE HCl

ACTUAL SIZE

NIGHTTIME

ACETAMINOPHEN

CHLORPHENIRAMINE MALEATE

DEXTROMETHORPHAN HBr

PHENYLEPHRINE HCl

†Antihistamine in Nighttime only

ACTUAL SIZE

Compare to the Active Ingredients in Tylenol® Cold Multi-Symptom Day and Night Caplets

Principal Display Panel
Cold Relief Carton Image 1 Cold Relief Carton Image 2

cold relief

Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:56062-250
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:56062-250-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-03-03


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