ROMPE TOS X ADULTS- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl syrup 
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.

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Rompe Tos X Adult

Drug Facts

Active ingredients

Purpose

Active ingredients (in each 20 mL)Purpose
Acetaminophen 500 mgPain reliever/fever reducer
Dextromethorphan HBr 26.66 mgCough suppressant
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal descongestant

Uses

temporarily relieves these common cold/flu symptoms:

Warnings

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 6 doses 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.

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.
  • for children under 12 years of age
  • 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
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • persistent or chronic cough sush as smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sodium restricted diet

When using this product

  • do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning

Taking more than recommended dose (overdose) may cause liver damaage. 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

AgeDose
adults and children 12 years of age and older20 mL in dosing cup provided every 4 hours
Children under 12 years of agedo not use

Other information

Inactive ingredients

Aloe vera, citric acid, disodium EDTA, FD&C red no. 40, hydroxyethyl cellulose, natural & artificial strawberry flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions?

Call 616-600-5632 MON to FRI, 9 a.m. to 6 p.m. PTZ

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

NDC 69729-785-06

Rompe Tos X

6 fl oz (177 mL)

Rompe Tos X Adult

ROMPE TOS X ADULTS 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-785
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE26.66 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
ALOE (UNII: V5VD430YW9)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-785-061 in 1 CARTON09/18/2023
1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/18/2023
Labeler - OPMX LLC (029918743)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639manufacture(69729-785)

Revised: 9/2023
Document Id: 05cd1600-0e39-f93a-e063-6294a90affd3
Set id: 05abb2db-d22e-90b5-e063-6294a90ace3f
Version: 2
Effective Time: 20230920
 
OPMX LLC