693t Kroger 41226 693 Acetaminophen Dextromethorphan Hydrobromide Phenylephrine Hydrochloride Ct 24

693t Kroger 41226 693 Acetaminophen Dextromethorphan Hydrobromide Phenylephrine Hydrochloride Ct 24
SPL v4
SPL
SPL Set ID bc00bbf8-52bb-fa75-e053-2a95a90a9406
Route
ORAL
Published
Effective Date 2021-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 70 Shape: oval Color: orange Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-11

Description

Acetaminophen 325 mg Dextromethorphan Hydrobromide 10 mg Phenylephrine Hydrochloride 5 mg


Medication Information

Warnings and Precautions

Warnings

Liver warning:


This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 softgels in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. symptoms may include:

  • Skin reddening
  • Blisters
  • Rash

If a skin 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 common cold/flu symptoms:
  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
Dosage and Administration

Directions

  • take only as directed
  • do not exceed 4 doses per 24 hr

adults & children 12 years & over: 2 softgels with water every 4 hrs

children 4 to under 12 yrs: ask a doctor.

children under 4 yrs: do not use

Description

Acetaminophen 325 mg Dextromethorphan Hydrobromide 10 mg Phenylephrine Hydrochloride 5 mg

Section 34088-5

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.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.
Section 50567-7

When using this product, do not use more than directed.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin .

Section 50569-3

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough 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.
Section 51727-6

Inactive ingredients FD&C red #40,FD&C yellow #6,gelatin,glycerin, polyethylene glycol, povidone,propylene glycol,purified water,shellac,sorbitol sorbitan solution,titanium dioxide.

Section 51945-4

Section 53413-1

Questions? 1-800-632-6900

Section 53414-9

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

Section 55105-1

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Section 55106-9

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 10 mg

Phenylephrine Hydrochloride 5 mg

Other Information

Other information

  • store at room temperature

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
Dosage and Administration (34068-7)

Directions

  • take only as directed
  • do not exceed 4 doses per 24 hr

adults & children 12 years & over: 2 softgels with water every 4 hrs

children 4 to under 12 yrs: ask a doctor.

children under 4 yrs: 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 8 softgels in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. symptoms may include:

  • Skin reddening
  • Blisters
  • Rash

If a skin 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 34088-5 (34088-5)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.
Section 50567-7 (50567-7)

When using this product, do not use more than directed.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin .

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough 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.
Section 51727-6 (51727-6)

Inactive ingredients FD&C red #40,FD&C yellow #6,gelatin,glycerin, polyethylene glycol, povidone,propylene glycol,purified water,shellac,sorbitol sorbitan solution,titanium dioxide.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-800-632-6900

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Section 55106-9 (55106-9)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 10 mg

Phenylephrine Hydrochloride 5 mg

Other Information (OTHER INFORMATION)

Other information

  • store at room temperature

Advanced Ingredient Data


Raw Label Data

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