Active Ingredients(In Each Gelcap)
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg
Day Time Gelcap
FDA Label NDC 59970-077
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Navarro Discount Pharmacies,llc for the product Day Time Gelcap (NDC 59970-077). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients(in each gelcap), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, do not exceed the recommended dosage., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
- nasal congestion
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
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.
- 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
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phegm(mucus)
- Persistent or chronic cough as occurs with smoking, asthma, emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
Taking the blood thinning drug warfarin.
When Using This Product, Do Not Exceed The Recommended Dosage.
Stop Use And Ask A Doctor If
- you get nervous, 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 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 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 to adults and children even if you do not notice any signs or symptoms.
Directions
- take only as directed-see Overdose warning
- do not exceed 4 doses per 24 hours
adults and children 12 yrs and over 2 GelCaps with water every 4 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
FDC red no. 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sobitol special
Package Label.Principal Display Panel
Daytime gelcap
Image Of Carton Label (Daytime.nav.carton)
Back Of Carton (Daytime.nav.carton2)
* Please review the disclaimer below.
