Desresfriol-dx Softgels

Desresfriol-dx Softgels
SPL v2
SPL
SPL Set ID ff5e0e0f-bfd2-b02b-e053-6394a90afe8a
Route
ORAL
Published
Effective Date 2023-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Acetaminophen (325 mg) Phenylephrine (5 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AP01 Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-30

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

Temporarily relieves common cold/flu symptoms:

  • Nasal congestion
  • Cough due to minor throat & bronchial irritation
  • Sore throat
  • Headache
  • Minor aches & pains
  • Fever
Section 42229-5

Made for:



RRX



Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you are: Taking the blood thinning drug warfarin.

Section 55105-1
Active ingredients (in each Softgel) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
Section 55106-9

Drug Facts

Directions
  • Take only as directed.
  • Do not exceed 4 doses per 24 hrs.
Adults & children 12 yrs & over 2 softgels with water every 4 hrs
Children 4 to under 12 yrs Ask a doctor
Children under 4 yrs Do not use
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.
Questions?

Call to free 619-600-5632 Monday throughFriday 9AM - 5PM EST

Allergy Alert

Acetaminophen may cause severe skin reactions. Symtoms may include:

  • Skin reddening blisters
  • Rash
  • If a skin reaction occurs, stop use and seek medical help right away.
Liver Warning

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

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Overdose Warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well for children even if you do not notice any signs or symptoms.

Other Information

Store at room temperature

Sore Throat Warning

If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Inactive Ingredients

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide.

Principal Display Panel

NDC 69729-121-10

Desresfriol-DX

Acetaminophen, Dextromethorphan, Phenylephrine

Flu&Cough

Gripe y Tos

Dolor de cuerpo/Body Aches

Fiebre/Fever

Dolor de Garganta/Sore Throat

Congestion Nasal/Nasal Congestion

Tos/Cough

10 Cápsulas Blandas de Gel/Softgels

When Using This Product,

do not use more than directed.

Stop Use and Ask A Doctor If
  • You get nervouz, dizzy or sleepless.
  • Symptoms get worse or last more than 5 days (children) or 7 days (adults).
  • Fever gets worse or lasts more than 3 days.
  • Redness or swelling is present.
  • New symtoms 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.

Ask A Doctor Before Use If You Have
  • Liver disease
  • Heart disease
  • Diabetes
  • High blood pressure
  • Trouble urinating due to enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • Persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema.

Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms:

  • Nasal congestion
  • Cough due to minor throat & bronchial irritation
  • Sore throat
  • Headache
  • Minor aches & pains
  • Fever
Section 42229-5 (42229-5)

Made for:



RRX



Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are: Taking the blood thinning drug warfarin.

Section 55105-1 (55105-1)
Active ingredients (in each Softgel) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
Section 55106-9 (55106-9)

Drug Facts

Directions
  • Take only as directed.
  • Do not exceed 4 doses per 24 hrs.
Adults & children 12 yrs & over 2 softgels with water every 4 hrs
Children 4 to under 12 yrs Ask a doctor
Children under 4 yrs Do not use
Do Not Use (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.
Questions?

Call to free 619-600-5632 Monday throughFriday 9AM - 5PM EST

Allergy Alert (Allergy alert)

Acetaminophen may cause severe skin reactions. Symtoms may include:

  • Skin reddening blisters
  • Rash
  • If a skin reaction occurs, stop use and seek medical help right away.
Liver Warning (Liver warning)

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

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Overdose Warning (Overdose warning)

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well for children even if you do not notice any signs or symptoms.

Other Information (Other information)

Store at room temperature

Sore Throat Warning (Sore throat warning)

If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Inactive Ingredients (Inactive ingredients)

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 69729-121-10

Desresfriol-DX

Acetaminophen, Dextromethorphan, Phenylephrine

Flu&Cough

Gripe y Tos

Dolor de cuerpo/Body Aches

Fiebre/Fever

Dolor de Garganta/Sore Throat

Congestion Nasal/Nasal Congestion

Tos/Cough

10 Cápsulas Blandas de Gel/Softgels

When Using This Product, (When using this product,)

do not use more than directed.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • You get nervouz, dizzy or sleepless.
  • Symptoms get worse or last more than 5 days (children) or 7 days (adults).
  • Fever gets worse or lasts more than 3 days.
  • Redness or swelling is present.
  • New symtoms 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, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • Liver disease
  • Heart disease
  • Diabetes
  • High blood pressure
  • Trouble urinating due to enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • Persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema.

Advanced Ingredient Data


Raw Label Data

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