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Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gels

Medically reviewed on June 15, 2017

Dosage form: capsule, liquid filled
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 5mg, ACETAMINOPHEN 250mg, GUAIFENESIN 200mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg
Labeler: Bayer HealthCare LLC.
NDC Code: 0280-0505

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.

Alka-seltzer Plus Severe Cough Mucus & Congestion LG

Drug Facts

Active ingredients (in each capsule)
Active ingredients (in each capsule)Purposes
Acetaminophen 250 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine hydrochloride 5 mgNasal decongestant

Purposes

Uses

· helps loosen phlegm (mucus) and thin bronchial secretions to rid

the bronchial passageways of bothersome mucus and make coughs

more productive

· temporarily relieves these symptoms due to a cold or flu:

· nasal congestion · sinus congestion and pressure

· minor aches and pains · headache

· cough · sore throat

· temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. 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

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic reaction occurs, stop use and seek medical

help right away.

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
  • in children under 12 years of age

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough with excessive 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
  • pain, cough, or nasal congestion 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 fever, rash or headache that lasts.
  • These could be signs of a serious condition.
  • nervousness, dizziness, or sleeplessness occurs

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. 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 the recommended dose
  • adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 12 capsules in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Other information
  • store at 15-25ºC (59-77ºF)

Inactive ingredients

FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol-sorbitan solution, titanium dioxide

Questions or comments? 1-800-986-03 69 (Mon-Fri 9AM - 5PM EST)

ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION  LIQUID GELS
alka-seltzer plus severe cough mucus and congestion capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0505
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
POLYETHYLENE GLYCOLS 
SORBITOL 
SODIUM HYDROXIDE 
TITANIUM DIOXIDE 
SHELLAC 
PROPYLENE GLYCOL 
POVIDONE 
FD&C RED NO. 40 
WATER 
GELATIN 
Product Characteristics
ColorredScoreno score
ShapeOVALSize20mm
FlavorImprint CodeAS;M
Contains    
Packaging
#Item CodePackage Description
1NDC:0280-0505-202 BLISTER PACK in 1 CARTON
120 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/07/2015
Labeler - Bayer HealthCare LLC. (112117283)

 
Bayer HealthCare LLC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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