Daytime Cold and Pain Relief description, usages, side effects, indications, overdosage, supplying and lots more!

Daytime Cold and Pain Relief

Safeway

  • 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
Safeway 44-503

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenyleprhine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

  • temporarily relieves these common cold/flu symptoms
    • minor aches and pains
    • headache
    • nasal congestion
    • sore throat
    • 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 for 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
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough 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 exceed recommended dosage.

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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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. 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)
  • 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; this will provide more than the recommended dose (overdose) and may cause liver damage 

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Principal Display Panel

NDC 21130-503-08

Compare to Tylenol ® Cold Multi-Symptom Severe Daytime active ingredients*

Day Time

Cold &
Pain Relief
with Cool Blast Flavor

Acetaminophen 325 mg,
Dextromethorphan HBr 10 mg,
Guaifenesin 200 mg,
Phenylephrine HCl 5 mg

Severe

Non-Drowsy
• Multi-Symptom
• Nasal Decongestant    • Cough Suppressant 
• Pain Reliever/Fever Reducer    • Expectorant

24 COOL CAPLETS

SAFEWAY™

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Head Congestion Severe Daytime.
50844     REV0512E50308

DISTRIBUTED BY SAFEWAY INC., P.O. BOX 99, PLEASANTON, CA 94566-009

QUALITY & SATISFACTION GUARANTEED OR YOUR MONEY BACK
1-888-SAFEWAY / www.safeway.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Principal Display Panel
Safeway 44-503C (Multi-Symptom)

Daytime Cold and Pain Relief

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21130-768
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
CROSPOVIDONE
D&C YELLOW NO. 10
MAGNESIUM STEARATE
maltodextrin
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
POVIDONES
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
YELLOW 19 mm 44;503 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:21130-768-24 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-08-04


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.