Daytime Cold and Flu Mini Softgels
- Dosage form
- CAPSULE, LIQUID FILLED
- Labeler
- Shield Pharmaceuticals Corp
- Label updated
- 2026-02-03
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN · DEXTROMETHORPHAN HYDROBROMIDE
Label information
Drug Facts
Active ingredient (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache n cough
- nasal congestion
- sore throat
- sinus congestion and pressure
- temporarily reduces fever
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 Softgels 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, persists for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Label information
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.
Label information
Ask a doctor before use if you have
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema
Label information
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Label information
When using this product
• do not use more than directed.
Label information
Stop use and ask a doctor if
• you get nervous, dizzy or sleepless
• 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.
Label information
If pregnant or breast-feeding,ask a health professional before use.
Label information
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Directions
- do not take more than the recommended dose
- adults & children 12 yrs & over: take 2 Softgels with water every 4 hrs. Do not exceed 10 softgels in 24 hours or as directed by a doctor
- children under 12 yrs: do not use
Other information
- store between 20-25°C (68-77°F).
- Avoid high humidity and excessive heat.
Questions or comments?
1-800-373-6981 (toll-free)
Inactive ingredients
FD&C Yellow No. 6, gelatin, glycerin, isopropyl alcohol, MCT Oil, polyethylene glycol-400, propylene glycol, povidone, purified water,
silver sheen, sorbitol solution
Label information
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
PRINCIPAL DISPLAY PANEL
Daytime Cold & Flu
Multi-Symptom Relief
mini softgels
Carton
[Image in the official label — see DailyMed source]
DailyMed Set ID: 63cb19d4-2306-4723-a95e-9d2d8b9eccd0 · Version 3
NDC: 83059-0128