FDA Label for Asp Daytime Pe
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH CAPSULE)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL - SHIPPING LABEL
Asp Daytime Pe Product Label
The following document was submitted to the FDA by the labeler of this product Humanwell Puracap Pharmaceutical (wuhan), Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Capsule)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/ fever reducer
Cough suppressant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
- cough due to minor throat & bronchial irritation
- nasal congestion
- sore throat
- headache
- minor aches/pains
- fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning: If sore throat is severe, persists more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
When Using This Product
- do not use more than directed
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.
Overdose Warning
Taking more than directed 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 and for children even if you do not notice any signs or symptoms.
Directions
- take only as directed - see Overdose warning
- do not exceed 4 doses per 24 hours
Adults and children 12 years of age and older | Swallow 2 softgels with water every 4 hours |
Children 4 to under 12 years of age | ask a doctor |
children under 4 years of age | do not use |
If taking NIGHTTIME and DAYTIME products, carefully read each label to insure correct dosing.
Other Information
- store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide
Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China
Principal Display Panel - Shipping Label
ASP Daytime PE Capsules
Quantity : 4000 Capsules
NDC. No : 53345-052-01
IMPORTANT:
Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
* Please review the disclaimer below.