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NDC 11673-0542-12 daytime severe cold and cough and nighttime severe cold and cough Details
daytime severe cold and cough and nighttime severe cold and cough
daytime severe cold and cough and nighttime severe cold and cough is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Target Corporation. The primary component is .
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 11673-0542-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 11673-0542-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 11673-0542-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 11673-0542-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 11673-0542 |
|---|---|
| Product ID | 11673-542_62eec235-431f-4429-b173-d4a9b45a4e36 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | daytime severe cold and cough and nighttime severe cold and cough |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | KIT |
| Route | n/a |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | Target Corporation |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 11673-0542-12 (11673054212)
| NDC Package Code | 11673-542-12 |
|---|---|
| Billing NDC | 11673054212 |
| Package | 1 KIT in 1 CARTON (11673-542-12) * 6 POWDER, FOR SOLUTION in 1 CARTON (11673-540-06) * 6 POWDER, FOR SOLUTION in 1 CARTON (11673-541-06) |
| Marketing Start Date | 2017-07-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 62eec235-431f-4429-b173-d4a9b45a4e36 Details
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
- •
- 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
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
Ask a doctor or pharmacist before use if you are - Nighttime Severe Cold and Cough
When using this product - Nighttime Severe Cold and Cough
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.
Keep out of reach of children.
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
|
Age |
Dose |
|
Adults and children 12 years of age and over |
One packet |
|
Children under 12 years of age |
Do not use |
- •
- 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
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.
|
Age |
Dose |
|
Adults and children 12 years of age and over |
One packet |
|
Children under 12 years of age |
Do not use |
- •
- 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
Other information - Daytime Severe Cold and Cough
Other information - Nighttime Severe Cold and Cough
Inactive ingredients - Daytime Severe Cold and Cough
Inactive ingredients - Nighttime Severe Cold and Cough
Package/Label Principal Display Panel
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 |
INGREDIENTS AND APPEARANCE
| DAYTIME SEVERE COLD AND COUGH AND NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl kit |
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| Labeler - Target Corporation (006961700) |