Alka-seltzer Plus Cold & Flu Fizzychews Ui 1615333

Alka-seltzer Plus Cold & Flu Fizzychews Ui 1615333
SPL v2
SPL
SPL Set ID 149330be-24bd-b4a4-e063-6394a90a9007
Route
ORAL
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Chlorpheniramine (2 mg) Acetaminophen (162.5 mg)
Inactive Ingredients
Sodium Starch Glycolate Type A Xylitol Anhydrous Citric Acid Stearic Acid Magnesium Stearate Mannitol Sucralose Silicon Dioxide Sodium Bicarbonate Betadex Microcrystalline Cellulose 102 Scg

Identifiers & Packaging

Pill Appearance
Imprint: ASP;11 Shape: round Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-01

Description

Drug Facts


Medication Information

Warnings and Precautions

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 to sedate children

Indications and Usage

Uses

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

· minor aches and pains · headache · cough

· runny nose · sneezing · sore throat

· temporarily reduces fever

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9



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 rash or headache that lasts. These

could be signs of a serious condition.

Section 50567-7

When using this product

● marked drowsiness may occur

● avoid alcoholic drinks

● excitability may occur, especially in children

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

Section 50568-5

Ask a doctor or pharmacist before use if you are

● taking the blood thinning drug warfarin

● taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

● liver disease ● glaucoma

● cough with excessive phlegm (mucus)

● a breathing problem such as emphysema or chronic bronchitis

● difficulty in urination due to enlargement of the prostate gland

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

● a sodium restricted diet

Section 50570-1

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

Section 51727-6

Inactive ingredients anhydrous citric acid, betadex,

carboxymethylcellulose, colloidal silicon dioxide, ethylcellulose, flavors,

magnesium searate, mannitol, microcrystalline cellulose, polyethylene,

sodium bicarbonate, sodium carbonate, sodium starch glycolate, stearic

acid, sucralose, xylitol

Section 51945-4

Alka-Seltzer®

PLUS

Orange Flavor

Cold

& Flu

FIZZY CHEWS

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/ Cough Supressant

Phenylephrine Hydrochloride/Nasal Decongestant

  • Cough
  • Runny Nose
  • Sneezing
  • Fever & Body Ache
  • Sore Throat

ACTIVATES

WITHOUT

WATER

24 CHEWABLE TABLETS

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55106-9

Active ingredients (in each tablet) Purposes

Acetaminophen 162.5 mg………….………...Pain reliever/fever reducer

Chlorpheniramine maleate 2 mg……………………..……..Antihistamine

Dextromethorphan hydrobromide 5 mg…….………Cough suppressant

Section 60561-8

Other information

each tablet contains: sodium 17 mg

● store at room temperature. Avoid excessive heat above 40 oC

(104 oF)

Directions

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 tablets every 4 hours.

Do not exceed 12 tablets in 24 hours or as directed by a doctor.

· do not swallow tablets whole. Chew or crush tablets completely

before swallowing.

· children under 12 years: do not use

Questions Or Comments

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)


Structured Label Content

Indications and Usage (34067-9)

Uses

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

· minor aches and pains · headache · cough

· runny nose · sneezing · sore throat

· temporarily reduces fever

Warnings and Precautions (34071-1)

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 to sedate children

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)



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 rash or headache that lasts. These

could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product

● marked drowsiness may occur

● avoid alcoholic drinks

● excitability may occur, especially in children

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

● taking the blood thinning drug warfarin

● taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

● liver disease ● glaucoma

● cough with excessive phlegm (mucus)

● a breathing problem such as emphysema or chronic bronchitis

● difficulty in urination due to enlargement of the prostate gland

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

● a sodium restricted diet

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients anhydrous citric acid, betadex,

carboxymethylcellulose, colloidal silicon dioxide, ethylcellulose, flavors,

magnesium searate, mannitol, microcrystalline cellulose, polyethylene,

sodium bicarbonate, sodium carbonate, sodium starch glycolate, stearic

acid, sucralose, xylitol

Section 51945-4 (51945-4)

Alka-Seltzer®

PLUS

Orange Flavor

Cold

& Flu

FIZZY CHEWS

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/ Cough Supressant

Phenylephrine Hydrochloride/Nasal Decongestant

  • Cough
  • Runny Nose
  • Sneezing
  • Fever & Body Ache
  • Sore Throat

ACTIVATES

WITHOUT

WATER

24 CHEWABLE TABLETS

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55106-9 (55106-9)

Active ingredients (in each tablet) Purposes

Acetaminophen 162.5 mg………….………...Pain reliever/fever reducer

Chlorpheniramine maleate 2 mg……………………..……..Antihistamine

Dextromethorphan hydrobromide 5 mg…….………Cough suppressant

Section 60561-8 (60561-8)

Other information

each tablet contains: sodium 17 mg

● store at room temperature. Avoid excessive heat above 40 oC

(104 oF)

Directions

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 tablets every 4 hours.

Do not exceed 12 tablets in 24 hours or as directed by a doctor.

· do not swallow tablets whole. Chew or crush tablets completely

before swallowing.

· children under 12 years: do not use

Questions Or Comments (Questions or comments)

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)


Advanced Ingredient Data


Raw Label Data

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