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634T Rite Aid 11822 8557 Maximum Strength Cold & Flu Relief


DRUG FACTS - Nighttime Cold & Flu


OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg


OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant


INDICATIONS & USAGE SECTION

Uses

temporarily relieves these symptoms due to a cold or flu:

temporarily reduces fever

  • minor aches and pains
  • headache
  • nasal and sinus congestion
  • cough
  • sore throat
  • runny nose
  • sneezing

WARNINGS SECTION

Warnings

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

Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions.

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 to sedate children.

  • 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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough with excessive phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers


OTC - WHEN USING SECTION

When using this product

  • do not exceed recommended dosage
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, & tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

OTC - STOP USE SECTION

Stop use and ask a doctor if

These could be signs of a serious condition.

  • nervousness, dizziness or sleeplessness occurs
  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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.


DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

OTHER SAFETY INFORMATION

Other information • store at room temperature • avoid temperatures above 25°C (77°F)


INACTIVE INGREDIENT SECTION

Inactive ingredientsFD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide


DRUG FACTS - Daytime Cold & Flu


OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5 mg


OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant


INDICATIONS & USAGE SECTION

Uses

temporarily relieves these symptoms due to a cold or flu:

temporarily reduces fever

  • minor aches and pains
  • headache
  • cough
  • sore throat
  • nasal and sinus congestion

WARNINGS SECTION

Warnings

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

Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions.

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.

  • 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

OTC - DO NOT USE SECTION

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


OTC - ASK DOCTOR SECTION

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


OTC - ASK DOCTOR/PHARMACIST SECTION

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


OTC - WHEN USING SECTION

When using this product, do not exceed recommended dosage


OTC - STOP USE SECTION

Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occurs • 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.


OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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.


DOSAGE FORMS & STRENGTHS SECTION

Directions

• do not take more than the recommended dose • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor. • children under 12 years: do not use


OTHER SAFETY INFORMATION

Other information • store at room temperature • avoid temperature above 25°C (77°F)


INACTIVE INGREDIENT SECTION

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


OTC - QUESTIONS SECTION

Questions or Comments?

Call 1-800-290-4008


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL