Cold & Flu - Gripa (acetaminophen 325mg; Dextromethorphan Hbr 10mg, Guaifenesin 200mg, Phenylephrine Hcl 5mg)

Cold & Flu - Gripa (acetaminophen 325mg; Dextromethorphan Hbr 10mg, Guaifenesin 200mg, Phenylephrine Hcl 5mg)
SPL v2
SPL
SPL Set ID 9239bf18-0e2b-20d5-e053-2a95a90addc8
Route
ORAL
Published
Effective Date 2018-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Phenylephrine (5 mg) Dextromethorphan (10 mg) Acetaminophen (325 mg)
Inactive Ingredients
Stearic Acid Croscarmellose Polyethylene Glycol 400 Food Yellow 3 Free Acid Dibasic Calcium Phosphate Dihydrate Microcrystalline Cellulose Silicon Dioxide Mica Magnesium Stearate Polysorbate 80 Talc Polyvinyl Alcohol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: S701 Shape: capsule Color: orange Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-12-20

Description

Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg


Medication Information

Warnings and Precautions

Liver warning:

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

  • more than 8 caplets in 24 hours, which is the maximum daily amount for this product
  • 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

Do not use

  • with any other drug containing acetaminophen (prescription or non prescription). 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 ths product
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostrate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthama, chronic bronchitis, or emphysema

Ask a doctor or a pharmacist before use if you are

  • taking the blood thinning drug warfarin

When using this product

  • do not use more than directed

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

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Indications and Usage

*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness

Dosage and Administration
  • take with a full glass of water
  • do not take more than directed
  • do not exceed 8 caplets per 24 hours
adults & children 12 years of age & over 2 caplets with water every 4 hours
children 4 to 12 years of age ask a doctor
children under 4 years of age do not use

Description

Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg

Section 50565-1

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C yellow#6, magnesium staerate, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, stearic acid, talc

Section 51945-4

Section 55105-1

Pain reliever / fever reducer, cough suppressant, expectorant, nasal decongestant

Section 55106-9

Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg

Section 60561-8
  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
  • avoid excessive heat and humidity

Structured Label Content

Indications and Usage (34067-9)

*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness

Dosage and Administration (34068-7)
  • take with a full glass of water
  • do not take more than directed
  • do not exceed 8 caplets per 24 hours
adults & children 12 years of age & over 2 caplets with water every 4 hours
children 4 to 12 years of age ask a doctor
children under 4 years of age do not use

Warnings and Precautions (34071-1)

Liver warning:

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

  • more than 8 caplets in 24 hours, which is the maximum daily amount for this product
  • 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

Do not use

  • with any other drug containing acetaminophen (prescription or non prescription). 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 ths product
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostrate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthama, chronic bronchitis, or emphysema

Ask a doctor or a pharmacist before use if you are

  • taking the blood thinning drug warfarin

When using this product

  • do not use more than directed

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

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C yellow#6, magnesium staerate, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, stearic acid, talc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain reliever / fever reducer, cough suppressant, expectorant, nasal decongestant

Section 55106-9 (55106-9)

Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg

Section 60561-8 (60561-8)
  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
  • avoid excessive heat and humidity

Advanced Ingredient Data


Raw Label Data

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