Kroger Acetaminophen 325 Mg, Dextromethorphan Hbr 10 Mg, Guaifenesin 200 Mg, Phenylehrine Hcl 5 Mg Tablets

Kroger Acetaminophen 325 Mg, Dextromethorphan Hbr 10 Mg, Guaifenesin 200 Mg, Phenylehrine Hcl 5 Mg Tablets
SPL v2
SPL
SPL Set ID 30d4a6c6-895e-3741-e063-6294a90ab192
Route
ORAL
Published
Effective Date 2025-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg) Acetaminophen (325 mg)
Inactive Ingredients
Silicon Dioxide Crospovidone Titanium Dioxide Triacetin Croscarmellose Sodium D&c Yellow No. 10 Aluminum Lake Magnesium Stearate Povidone Hypromellose, Unspecified Microcrystalline Cellulose Talc

Identifiers & Packaging

Pill Appearance
Imprint: D1 Shape: oval Color: yellow Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-26

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Liver warning:  This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 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

  • for the temporary relief of the following cold/flu symptoms:

- minor aches and pains

- headache

- sore throat

- nasal congestion

- cough

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever
Dosage and Administration

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 10 caplets in 24 hours
children under 12 years

ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Overdose warning:  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 50566-9

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
  • 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 exceed recommended dose

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 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)
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.

Section 51727-6

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C yellow no. 10 al. lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc, titanium dioxide, triacetin

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-632-6900

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Section 60561-8

Other information

  • each caplet contains: sodium 3 mg
  • store at room temperature, between 20º - 25ºC (68º - 77ºF), and avoid excessive heat and humidity

Structured Label Content

Indications and Usage (34067-9)

Uses

  • for the temporary relief of the following cold/flu symptoms:

- minor aches and pains

- headache

- sore throat

- nasal congestion

- cough

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever
Dosage and Administration (34068-7)

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 10 caplets in 24 hours
children under 12 years

ask a doctor

Warnings and Precautions (34071-1)

Warnings

Liver warning:  This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 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 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning:  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 50566-9 (50566-9)

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
  • 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 exceed recommended dose

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 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)
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.

Section 51727-6 (51727-6)

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C yellow no. 10 al. lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc, titanium dioxide, triacetin

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 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)

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Section 60561-8 (60561-8)

Other information

  • each caplet contains: sodium 3 mg
  • store at room temperature, between 20º - 25ºC (68º - 77ºF), and avoid excessive heat and humidity

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)