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.

Active Ingredient

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

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

Structured Label Content

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.

Active Ingredient (55106-9)

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

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

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 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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