ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- CAPSULE, LIQUID FILLED
- Labeler
- SPIRIT PHARMACEUTICALS, LLC
- Label updated
- 2010-09-01
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN · DEXTROMETHORPHAN HYDROBROMIDE · PHENYLEPHRINE HYDROCHLORIDE
Label information
Drug Facts
유효 성분
성분·작용
| Active ingredients (in each LiquiCap) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
Warnings
Label information
Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.
Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Label information
Do not use
- with other medicines containing acetaminophen
- 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
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- 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
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
- 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.
Label information
If pregnant or breast-feeding, ask a health professional before use.
Label information
Keep out of reach of children.
Label information
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.
Directions
- take only as recommended - see Overdose warning
- do not exceed 6 doses per 24 hours
| adults and children 12 years and over | 2 LiquiCaps with water every 4 hours |
| children under 12 years | ask a doctor |
- when using other DayQuil or NyQuil products, carefully read each label to insure correct dosing
Other information
- store at room temperature
Inactive ingredients
FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide
Questions?
1-800-251-3374
PRINCIPAL DISPLAY PANEL
Acetaminophen, Dextromethorphan HBr Phenylephrine HCL capsules
Each Softgel Contains:
(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg,
Phenylephrine Hydrochloride USP 5mg)
LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 68210-0101-
EXP DATE:
WARNING:
KEEP OUT OF REACH OF CHILDREN
STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.
MANUFACTURED BY:
SOFTGEL HEALTHCARE PVT LIMITED
INDIA
LABELLER CODE: 35916
LIC NO.: TN/DRUGS/00002124
MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039
CAUTION: "FOR MANUFACTURING, PROCESSING OR REPACKING"
- 1 – 4
- 2 – 100
- 3 – 1000
- 4 – 5000
- 5 – 10000
6 - 2500
[Image in the official label — see DailyMed source]
DailyMed Set ID: 17aebf77-55d8-4a02-8391-28bbd9c3b373 · Version 2
NDC: 68210-0101