627t Rite Aid 11822 8554 Severe Cold & Flu Relief 24 Ct

627t Rite Aid 11822 8554 Severe Cold & Flu Relief 24 Ct
SPL v2
SPL
SPL Set ID ad165e36-2704-3527-e053-2995a90a6d2a
Route
ORAL
Published
Effective Date 2020-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Acetaminophen (325 mg) Guaifenesin (200 mg) Phenylephrine (5 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Fd&c Red No. 40 Water Fd&c Blue No. 1 Gelatin Glycerin Shellac Sorbitol Polyethylene Glycol 400 Titanium Dioxide Povidone Propylene Glycol Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 72 Shape: bullet Color: orange Color: green Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-08-03

Description

DAY SEVERE COLD AND FLU


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 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

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Dosage and Administration

Directions

  • take only as directed
  • do not exceed 8 softgels per 24 hrs

adults & children 12 yrs & over: 2 softgels with water every 4 hours.

children 4 to under 12 yrs: ask a doctor

children under 4 yrs: do not use

Description

DAY SEVERE COLD AND FLU

Section 50565-1

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.

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 such as occurs with smoking, asthma, chronic bronchitis, 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 blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Section 51945-4

Section 53413-1

Questions or Comments?

call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Section 60561-8

Other information

  • do not exceed 25°C
Daytime Cold and Flu

DAY SEVERE COLD AND FLU

Nighttime Cold & Flu

NIGHT SEVERE COLD AND FLU


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Dosage and Administration (34068-7)

Directions

  • take only as directed
  • do not exceed 8 softgels per 24 hrs

adults & children 12 yrs & over: 2 softgels with water every 4 hours.

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 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 50565-1 (50565-1)

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.

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 such as occurs with smoking, asthma, chronic bronchitis, 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 blue #1, FD&C red #40, 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 or Comments?

call 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Section 60561-8 (60561-8)

Other information

  • do not exceed 25°C
Daytime Cold and Flu (DAYTIME COLD AND FLU)

DAY SEVERE COLD AND FLU

Nighttime Cold & Flu (NIGHTTIME COLD & FLU)

NIGHT SEVERE COLD AND FLU


Advanced Ingredient Data


Raw Label Data

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