Alka-seltzer Plus Maximum Strength Day And Light Cold And Flu Liquid Gels (project Fortify)

Alka-seltzer Plus Maximum Strength Day And Light Cold And Flu Liquid Gels (project Fortify)
SPL v5
SPL
SPL Set ID b13d5132-cb91-3cf6-e053-2a95a90aa47c
Route
ORAL
Published
Effective Date 2020-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Phenylephrine (5 mg) Acetaminophen (325 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Glycerin Water Polyethylene Glycol, Unspecified Sorbitol Fd&c Red No. 40 Titanium Dioxide Shellac Sodium Hydroxide Fd&c Yellow No. 6 Gelatin, Unspecified Propylene Glycol Povidone Sorbitan Gelatin Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Imprint: AS;NITE Shape: oval Color: orange Color: green Size: 20 mm Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-26

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.

Indications and Usage

Uses

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

· minor aches and pains · headache · cough

· sore throat · nasal and sinus congestion

· temporarily reduces fever

Dosage and Administration

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 10 capsules in 24 hours or as

directed by a doctor.

· children under 12 years: do not use

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.

· nervousness, dizziness, or sleeplessness occurs

Section 50567-7

When using this product do not exceed recommended dosage.

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 ● heart disease ● high blood pressure

● thyroid disease ● diabetes

● cough with excessive phlegm (mucus)

● difficulty in urination due to enlargement of the prostate gland

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

or emphysema

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 FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Section 51945-4

Alka-Seltzer Plus®

DAY NON-DROWSY

ACETAMINOPHEN / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppresant

Phenylephrine HCl / Nasal Decongestant

  • Nasal Congestion
  • Headache & Body Ache
  • Cough
  • Sore Throat
  • Sinus Congestion

12 LIQUID GELS

(LIQUID-FILLED CAPSULES)

Night

ACETAMINOPHEN / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppresant

Doxylamine Succinate / Antihistamine

Phenylephrine HCl / Nasal Decongestant

  • Nasal Congestion
  • Headache & Body Ache
  • Cough
  • Runny Nose
  • Sore Throat

8 LIQUID GELS

(LIQUID FILLED CAPSULES)

Section 53413-1

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

Section 53414-9

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

Section 55106-9

Active ingredients (in each capsule) Purposes

Acetaminophen 325 mg…………….……….Pain reliever/fever reducer

Dextromethorphan hydrobromide 10 mg…………..Cough suppressant

Phenylephrine hydrochloride 5 mg…………………Nasal decongestant

Section 60561-8

Other information

● store at room temperature. Avoid excessive heat above 40°C

(104°F).

Directions

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 10 capsules in 24 hours or as

directed by a doctor.

· children under 12 years: do not use

Other Information

Other information

● store at room temperature. Avoid excessive heat above 40°C

(104°F).


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

· sore throat · nasal and sinus congestion

· temporarily reduces fever

Dosage and Administration (34068-7)

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 10 capsules in 24 hours or as

directed by a doctor.

· children under 12 years: do not use

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.

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.

· nervousness, dizziness, or sleeplessness occurs

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage.

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 ● heart disease ● high blood pressure

● thyroid disease ● diabetes

● cough with excessive phlegm (mucus)

● difficulty in urination due to enlargement of the prostate gland

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

or emphysema

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 FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Section 51945-4 (51945-4)

Alka-Seltzer Plus®

DAY NON-DROWSY

ACETAMINOPHEN / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppresant

Phenylephrine HCl / Nasal Decongestant

  • Nasal Congestion
  • Headache & Body Ache
  • Cough
  • Sore Throat
  • Sinus Congestion

12 LIQUID GELS

(LIQUID-FILLED CAPSULES)

Night

ACETAMINOPHEN / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppresant

Doxylamine Succinate / Antihistamine

Phenylephrine HCl / Nasal Decongestant

  • Nasal Congestion
  • Headache & Body Ache
  • Cough
  • Runny Nose
  • Sore Throat

8 LIQUID GELS

(LIQUID FILLED CAPSULES)

Section 53413-1 (53413-1)

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

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 capsule) Purposes

Acetaminophen 325 mg…………….……….Pain reliever/fever reducer

Dextromethorphan hydrobromide 10 mg…………..Cough suppressant

Phenylephrine hydrochloride 5 mg…………………Nasal decongestant

Section 60561-8 (60561-8)

Other information

● store at room temperature. Avoid excessive heat above 40°C

(104°F).

Directions

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 10 capsules in 24 hours or as

directed by a doctor.

· children under 12 years: do not use

Other Information (Other information)

Other information

● store at room temperature. Avoid excessive heat above 40°C

(104°F).


Advanced Ingredient Data


Raw Label Data

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