775l - target - nighttime severe liquid berry

775l - target - nighttime severe liquid berry
SPL v1
SPL
SPL Set ID 1cf3064d-4ddd-63b9-e063-6294a90aa547
Route
oral
Published
Effective Date 2024-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (20 mg) acetaminophen (650 mg) doxylamine (12.5 mg) phenylephrine (10 mg)
Inactive Ingredients
propylene glycol fd&c blue no. 1 sodium benzoate sodium chloride sodium citrate xanthan gum sorbitol solution water saccharin sodium fd&c red no. 40 sucralose glycerin citric acid monohydrate polyethylene glycol, unspecified

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph drug active Since 2024-06-30

Description

Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg


Medication Information

Warnings and Precautions



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

• more than 4 doses 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.

Active Ingredient

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Indications and Usage

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
Dosage and Administration

Directions

• take only as directed

• only use the dose cup provided

• do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over 30 mL every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Description

Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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


• excitability may occur, especially in children

• marked drowsiness may occur

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives, and tranquilizers may increase drowsiness

Section 50568-5



Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

• 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

• glaucoma

• cough that occurs with too much phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

• trouble urinating due to enlarged prostate gland

• a sodium-restricted diet

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 citric acid monohydrate, FD&C blue no.1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-910-6874

Section 53414-9

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

Section 55105-1

Purpose



Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Section 60561-8

Other information

each 30 mL contains: sodium 98 mg

• store at no greater than 25℃ and do not refrigerate


Structured Label Content

Warnings and Precautions (34071-1)



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

• more than 4 doses 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.

Active Ingredient (55106-9)

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Indications and Usage (34067-9)

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
Dosage and Administration (34068-7)

Directions

• take only as directed

• only use the dose cup provided

• do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over 30 mL every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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


• excitability may occur, especially in children

• marked drowsiness may occur

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives, and tranquilizers may increase drowsiness

Section 50568-5 (50568-5)



Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

• 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

• glaucoma

• cough that occurs with too much phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

• trouble urinating due to enlarged prostate gland

• a sodium-restricted diet

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 citric acid monohydrate, FD&C blue no.1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-910-6874

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose



Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Section 60561-8 (60561-8)

Other information

each 30 mL contains: sodium 98 mg

• store at no greater than 25℃ and do not refrigerate


Advanced Ingredient Data


Raw Label Data

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