Drug Facts
fa0ce51f-441d-4409-8617-b3402b00f187
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 325 mg Phenylephrine HCl 5 mg
Purpose
Pain reliever/Fever reducer Nasal decongestant
Medication Information
Purpose
Pain reliever/Fever reducer Nasal decongestant
Description
Acetaminophen 325 mg Phenylephrine HCl 5 mg
Uses
- temporarily relieves these symptoms due to the common cold or flu:
- nasal congestion
- stuffy nose
- sore throat
- headache
- sinus congestion and pressure
- minor aches and pains
- temporarily reduces fever
Purposes
Pain reliever/Fever reducer
Nasal decongestant
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount
- 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, ask a doctor promptly.
Directions
- do not take more than directed(see overdose warning)
- adults and children 12 years of age and over: take 2 caplets every 4 hours, while symptoms persist or as directed by a doctor
- do not take more than 12 caplets in 24 hours, unless directed by a doctor
- children under 12 years of age: ask a doctor
- swallow whole – do not crush, chew or dissolve
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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Other Information
- store below 25°C (77°F)
Overdose Warning:
Taking more than the recommended dose 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 as for children even if you do not notice any signs or symptoms.
Inactive Ingredients
crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Principal Display Panel
NDC 0135-7031-01
Panadol
COLD+FLU
NON-DROWSY
ACETAMINOPHEN
Pain Reliever/Fever Reducer
PHENYLEPHRINE HCl
Nasal Decongestant
50 PACKETS
2 CAPLETS PER PACKET
TAMPER-EVIDENT FEATURE: This product is protected in a sealed blister. Do not use if blister or printed foil is broken.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
Trademarks are owned by or licensed to the GSK group of companies.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
©2022 GSK group of companies or its licensor.
000079491 Front Carton
Stop Use and Ask A Doctor If
- you get nervous, dizzy or sleepless
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
These could be signs of a serious condition.
If Pregnant Or Breast Feeding,
ask a health professional before use.
Active Ingredients (in Each Caplet)
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Ask A Doctor Before Use If You Have
- liver disease
- diabetes
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
Structured Label Content
Uses
- temporarily relieves these symptoms due to the common cold or flu:
- nasal congestion
- stuffy nose
- sore throat
- headache
- sinus congestion and pressure
- minor aches and pains
- temporarily reduces fever
Purposes
Pain reliever/Fever reducer
Nasal decongestant
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount
- 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, ask a doctor promptly.
Directions
- do not take more than directed(see overdose warning)
- adults and children 12 years of age and over: take 2 caplets every 4 hours, while symptoms persist or as directed by a doctor
- do not take more than 12 caplets in 24 hours, unless directed by a doctor
- children under 12 years of age: ask a doctor
- swallow whole – do not crush, chew or dissolve
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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Other Information (Other information)
- store below 25°C (77°F)
Overdose Warning: (Overdose warning:)
Taking more than the recommended dose 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 as for children even if you do not notice any signs or symptoms.
Inactive Ingredients (Inactive ingredients)
crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Principal Display Panel
NDC 0135-7031-01
Panadol
COLD+FLU
NON-DROWSY
ACETAMINOPHEN
Pain Reliever/Fever Reducer
PHENYLEPHRINE HCl
Nasal Decongestant
50 PACKETS
2 CAPLETS PER PACKET
TAMPER-EVIDENT FEATURE: This product is protected in a sealed blister. Do not use if blister or printed foil is broken.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
Trademarks are owned by or licensed to the GSK group of companies.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
©2022 GSK group of companies or its licensor.
000079491 Front Carton
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- you get nervous, dizzy or sleepless
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
These could be signs of a serious condition.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use.
Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- liver disease
- diabetes
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
taking the blood thinning drug warfarin
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:03:16.059190 · Updated: 2026-03-14T23:03:14.317302