FDA Label for Daytime Nighttime Cold And Flu
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Daytime Nighttime Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens. 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.
Otc - Active Ingredient
Daytime Cold & Flu
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Nighttime Cold & Flu
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Otc - Purpose
Daytime Cold & Flu
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Nighttime Cold & Flu
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Indications & Usage
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion (Daytime only)
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- aches and pains
- fever
- runny nose and sneezing (Nighttime only)
Warnings
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
- wilh other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- Skin reddening
- Blisters
- Rash
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.
Otc - Do Not Use
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.
Otc - Ask Doctor
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)
- glaucoma (Nighttime only)
- a breathing problems or chronic cough that lasts or as occurs with smoking, asthma,chronic bronchitis, or emphysema (Nighttime only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
Otc - When Using
When using this product
- do not use more than directed
- excitability may occur, especially in children (Nighttime only)
- marked drowsiness may occur (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
- avoid alcoholic drinks (Nighttime only)
- be careful when driving a motor vehicle or operating machinery
(Nighttime only)
Otc - Stop Use
Stop use and ask a doctor If
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough get worse or last more than 7days
- 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center righl 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.
Dosage & Administration
Directions
- take only as directed
- do not exceed 4 doses per 24 hrs
adults & children 12yrs & over: 2 softgels with water every 6 hrs(Nighttime only)
2 softgels with water every 6 hrs (Daytime only)
children 4 to under12 yrs: ask a doctor
children under 4 yrs: do not use
Other Information
Other information
- store at room temperature
Inactive Ingredient
Inactive ingredients (Daytime only)
FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.
Inactive ingredients (Nighttime only)
FD&C blue #1, FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.
Otc - Questions
Questions? Call 1-877-290-4008
* Please review the disclaimer below.