for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever
do not take more than directed (see OVERDOSE WARNING) adults and children 12 years and over take 2 caplets every 4 hours swallow whole; do not crush, chew or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor
each caplet contains: sodium 3 mg store between 20-25°C (68-77°F) do not use if blister unit is torn or broken
Drug Facts
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product do not exceed recommended dose
These could be signs of a serious condition.
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
do not take more than directed (see OVERDOSE WARNING)
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
carnauba wax, croscarmellose sodium, D&C yellow no. 10 aluminum lake, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sucralose, titanium dioxide
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
| Active ingredients (in each caplet) | Purpose |
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
TYLENOL ®
FOR ADULTS
COLD + FLU
SEVERE
Acetaminophen,
Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Cough Suppressant,
Nasal Decongestant, Expectorant
HEAD + BODY ACHES
FEVER + SORE THROAT
COUGH
NASAL CONGESTION
MUCUS + CHEST
CONGESTION
2 Pouches of 2 Caplets each
TYLENOL ®
FOR ADULTS
COLD + FLU
SEVERE
Acetaminophen,
Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Cough Suppressant,
Nasal Decongestant, Expectorant
HEAD + BODY ACHES
FEVER + SORE THROAT
COUGH
NASAL CONGESTION
MUCUS + CHEST
CONGESTION
25 Pouches of 2 Caplets each
TYLENOL ®
FOR ADULTS
COLD + FLU
SEVERE
Acetaminophen,
Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Cough Suppressant,
Nasal Decongestant, Expectorant
HEAD + BODY ACHES
FEVER + SORE THROAT
COUGH
NASAL CONGESTION
MUCUS + CHEST
CONGESTION
30 Pouches of 2 Caplets each
TYLENOL ®
FOR ADULTS
COLD + FLU
SEVERE
Acetaminophen,
Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Cough Suppressant,
Nasal Decongestant, Expectorant
HEAD + BODY ACHES
FEVER + SORE THROAT
COUGH
NASAL CONGESTION
MUCUS + CHEST
CONGESTION
4 Caplets
2 Pouches of 2 Caplets each
CVP
HEALTH
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 29485-8062 | 29485-8062-3, 29485-8062-2 |
| 29485-8060 | 29485-8060-4 |
| 29485-6556 | 29485-6556-4 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4615ac9d-d9fc-8d06-e063-6294a90a64cc | d3315908-ebc3-e7cd-e053-2a95a90ae9a3 | 2025-12-16 | Warnings | 4615ac9d-d9fc-8d06-e063-6294a90a64cc d3315908-ebc3-e7cd-e053-2a95a90ae9a3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.