OTC Medication Information: Viro Flu PM Relief

VIRO FLU PM RELIEF- dextromethorphan hydrobromide, doxylamine succinate and acetaminophen capsule, liquid filled
OPMX LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients (in each Softgels) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine

Uses

Temporarily relieves common cold/flu symptoms:

  • Cough due to minor throat & bronchial irritation
  • Sore throat
  • Headache
  • Minor aches & pains
  • Fever
  • Runny nose & sneezing

Warnings

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

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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

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.

Ask a doctor before use if you have

  • liver disease
  • 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

When using this product

  • 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, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • Pain 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 overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

  • Take only as directed
  • Do not exceed 4 doses per 24 hrs
Adults & children 12 yrs & over 2 softgels with water every 6 hrs
Children 4 to under 12 yrs Ask a doctor
Children under 4 yrs Do not use

Other information

  • Store at room temperature

Inactive ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

Questions?

Call toll free 619-600-5632 Monday through Friday 9AM — 5PM EST

Made for:

RRX Exclusively distributed by:

OPMX Chula Vista, CA 91910

PRINCIPAL DISPLAY PANEL

NDC 69729-057-10

Viro-Flu PM

  • Cough/ Tos
  • Cold/Resfriado
  • Nasal Congestion & Runny Nose/ Flujo y congestion nasal
  • Sore Throat/ Ardor de Garganta
  • Headache and Body Ache/ Dolor de Cabeza y Cuerpo
  • Cought/Tos
  • Flu/ Gripe

10 Sofgels

Viro-Flu PM Relief
(click image for full-size original)

VIRO FLU PM RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-057
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 6.25 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
WATER
SORBITOL
TITANIUM DIOXIDE
Product Characteristics
Color green Score no score
Shape OVAL Size 20mm
Flavor Imprint Code AP02
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69729-057-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (69729-057-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/10/2022
Labeler — OPMX LLC (029918743)
Establishment
Name Address ID/FEI Operations
Health Pharma USA LLC 080804485 label (69729-057), manufacture (69729-057), pack (69729-057)

Revised: 06/2022 OPMX LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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