D — TIME- acetaminophen, phenylephrine hydrochloride and dextromethorphan hydrobromide capsule, liquid filled
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
|Active ingredients (in each LiquiCap)||Purpose|
|Acetaminophen 325mg||Pain reliever/Fever Reducer|
|Dextromethorphan Hbr 10mg||Cough Suppressant|
|Phenylephrine HCl 5 mg||Nasal Decongestant|
temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- minor aches and pains
- nasal congestion
Alcohol Warnings : if you consume 3 or more alcoholic drinks every day, ask you 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.
- 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.
- heart disease
- thyroid disease
- high blood pressure
- trouble urinating due to enlarged postage gland
- cough that occurs with too much phlegm(mucus)
- persistent or chronic cough as occurs with smoking, asthma or emphyesma
when using this product do not use more than directed
- you get nervous,dizzy or sleepless
- symptoms get worse or last more than 5 days (children) or 7 days (adults)
- fever gets worse or less tan 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 conditions
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children.
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.
- take only as recommended – see Overdose warning
- do not exceed 6 doses per 24 Hours
|adults and children 12 years of age and older||-2 liquicaps with water every 4 hours|
|children under 12 years of age||- ask a doctor|
- each tablet contains: Store at room temperature
FD &C Red No 40 IH, Polyethylene Glycol 400, Gelatin, Glycerin, Povidone, Purified water, Sorbitol
D-Time Soft Gelatin Capsules
|Each soft gelatin capsule contains :|
|Acetaminophen USP||325 mg|
|Phenylephrine Hydrochloride USP||5 mg|
|Dextromethorphan Hydrobromide USP||10 mg|
|LOT NO :||NDC NO : 68210-1490-6|
|MFG DATE :||QUANTITY : 1000 X 6 Softgels|
|EXP. DATE :||GROSS WT. :|
WARNING: KEEP OUT OF REACH OF CHILDREN
STORE AT CONTROLLED ROOM TEMPERATURE OF 59° — 86°F (15° — 30 °C) PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS BULK SHIPMENT IS INTENDED FOR FURTHER PACKAGING PROCESS ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FD & C ACT AND REGULATIONS THEREUNDER.
Marksans Pharma Ltd
CODE : GO/DRUGS/515
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”
| D — TIME |
acetaminophen, phenylephrine hydrochloride, and dextromethorphan hydrobromide capsule, liquid filled
|Labeler — SPIRIT PHARMACEUTICALS,LLC (179621011)|
Revised: 07/2010 SPIRIT PHARMACEUTICALS,LLC
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.