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

cold relief

Western Family Foods 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
Western Family Cold Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

  • for the temporary relief of the following cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough
  • impulse to cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

Warnings

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, chronic bronchitis 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

  • you get nervous, dizzy or sleepless
  • 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

  • do not take more than directed (see Liver warning)
adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole – do not crush, chew or dissolve
  • do not take more than 12 caplets in 24 hours
children under 12 years
  • do not use this adult product in children under 12 years of age

Other information

  • each caplet contains: sodium 3 mg

Inactive ingredients

acesulfame potassium, carnauba wax, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Principal Display Panel

See New Warnings Information

Multi-Symptom

SEVERE CONGESTION

Cold Relief

ASPIRIN FREE

Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant, Expectorant

DAYTIME

Fever/Headache/Sore Throat – Acetaminophen

Nasal Congestion – Phenylephrine HCl

Coughing – Dextromethorphan HBr

Chest Congestion – Guaifenesin

Gluten Free

COOL ICE® CAPLETS

Instant Cooling Sensation

COMPARE TO TYLENOL® COLD MULTI-SYMPTOM SEVERE active ingredients

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

cold relief

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55312-308
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Guaifenesin GUAIFENESIN 200 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
carnauba wax
CROSCARMELLOSE SODIUM
CROSPOVIDONE
maltodextrin
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
povidone
SILICON DIOXIDE
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
YELLOW 20 mm L234 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:55312-308-62 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1992-09-11


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Be sure to consult your doctor before taking any medication!
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