Active Ingredients (In Each Packet) – Daytime Severe Cold And Cough
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Daytime Severe Cold And Cough And Nighttime Severe Cold And Cough Kit
FDA Label NDC 11673-542
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Daytime Severe Cold And Cough And Nighttime Severe Cold And Cough (NDC 11673-542). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each packet) – daytime severe cold and cough, active ingredients (in each packet) - nighttime severe cold and cough, purposes - daytime severe cold and cough, purpose - nighttime severe cold and cough, uses - daytime severe cold and cough, uses - nighttime severe cold and cough, warnings – daytime severe cold and cough and nighttime severe cold and cough, do not use - daytime severe cold and cough, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Packet) - Nighttime Severe Cold And Cough
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Purposes - Daytime Severe Cold And Cough
Pain reliever/fever reducer
Cough Suppressant
Nasal Decongestant
Purpose - Nighttime Severe Cold And Cough
Pain reliever/fever reducer
Antihistamine/cough Suppressant
Nasal Decongestant
Uses - Daytime Severe Cold And Cough
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
- minor sore throat pain
- headache
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Uses - Nighttime Severe Cold And Cough
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
- minor sore throat pain
- headache
- nasal and sinus congestion
- runny nose
- sneezing
- itchy nose or throat
- itchy, watery eyes due to hay fever
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Warnings – Daytime Severe Cold And Cough And Nighttime Severe Cold And Cough
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
●Skin reddening● blisters● rash
Is 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.
Do Not Use - Daytime Severe Cold And Cough
- in a child under 12 years of age
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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.
Do Not Use - Nighttime Severe Cold And Cough
- in a child under 12 years of age
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
- with any other product containing diphenhydramine, even one used on skin
- 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 a MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have - Daytime Severe Cold And Cough
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
Ask A Doctor Before Use If You Have - Nighttime Severe Cold And Cough
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are - Daytime Severe Cold And Cough
taking the blood thinning drug warfarin
Ask A Doctor Or Pharmacist Before Use If You Are - Nighttime Severe Cold And Cough
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product - Daytime Severe Cold And Cough
do not exceed recommended dosage
When Using This Product - Nighttime Severe Cold And Cough
- do not exceed recommended dosage
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop Use And Ask A Doctor If – Daytime Severe Cold And Cough /Nighttime Severe Cold And Cough
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions – Daytime Severe Cold And Cough
- do not use more than directed
- take every 4 hours, while symptoms persist, Do not take more than 5 packets in 24 hours unless directed by a doctor
- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
- if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat
Age | Dose |
Adults and children 12 years of age and over | One packet |
Children under 12 years of age | Do not use |
Directions Nighttime Severe Cold And Cough
- do not use more than directed
- take every 4 hours, while symptoms persist, Do not take more than 5 packets in 24 hours unless directed by a doctor.
- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
- if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat
Age | Dose |
Adults and children 12 years of age and over | One packet |
Children under 12 years of age | Do not use |
Other Information - Daytime Severe Cold And Cough
- each packet contains: potassium 6 mg
- store at room temperature. Protect from excessive heat and moisture
Other Information - Nighttime Severe Cold And Cough
- each packet contains: potassium 6 mg
- store at room temperature. Protect from excessive heat and moisture
Inactive Ingredients - Daytime Severe Cold And Cough
citric acid ,FD&C blue#1, FD&C red 40#, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose
Inactive Ingredients - Nighttime Severe Cold And Cough
citric acid, FD & C yellow #6, flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose,
Questions Or Comments?
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Compare to active ingredients in Theraflu® Daytime Severe Cold and Cough and Nighttime Severe Cold & Cough*
Value pack
daytime severe cold and cough
acetaminophen(pain reliever/ fever reducer)
dextromethorphan HBr ( cough suppressant)
phenylephrine HCl ( nasal decongestant)
aspartame free, sodium free
relief of nasal and sinus congestion,, cough ,body ache, sore throat pain, headache ,fever
berry flavor
infused with menthol and green tea flavors
6 PACKETS
nighttime severe cold and cough
acetaminophen –(pain reliever/ fever reducer)
diphenhydramine HCl – (antihistamine/ cough suppressant)
phenylephrine HCl – (nasal decongestant)
aspartame free, sodium free
relief of nasal congestion,, cough ,runny nose, sneezing, body ache, sore throat pain, headache ,fever
honey lemon flavor infused with chamomile & white tea flavors
6 PACKETS
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE .KEEP CARTON FOR REFERENCE, DO NOT DISCARD. |
DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 –HOUR PERIOD. |
DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF DAYTIME PRODUCT UNLESS DIRECTED BY DOCTOR. |
*These Products are not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Daytime Severe Cold & Cough and Theraflu Nighttime severe Cold & Cough
Distributed by: Target Corporation.
Minneapolis, MN 55403
TM &©2017 Target Brands, Inc.
Tamper Evident Inner Unit Do not use if sealed packet is Torn or Broken |
Up & Up Daytime Severe Cold And Cough And Nighttime Severe Cold And Cough Value Pack (49516a11 E910 4ce0 Be95 F9f6e78b9df5 01)
* Please review the disclaimer below.
