Indications and uses
• 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
daytime severe cold and cough and nighttime severe cold and cough
- Manufacturer
- Target Corporation
- Effective date
- 2018-01-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:54:13
Label at a glance#
Productdaytime severe cold and cough and nighttime severe cold and cough
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure25 sections
Dosage and administration
• 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 pa...
Storage and handling
• each packet contains: potassium 6 mg • store at room temperature. Protect from excessive heat and moisture
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each packet) – Daytime Severe Cold and Cough
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
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
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
- 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?
1-866-467-2748
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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1428880 | {1 (acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) } Pack | GPCK | 1 |
| 1428880 | 1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packets for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Packets for Oral Solution) Pack | PSN | 1 |
| 1659967 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | 1 |
| 1659967 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | 1 |
| 1428880 | 1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packets for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packets for Oral Solution) Pack | SY | 1 |
| 1659967 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral Solution | SY | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | 1 |
| 1659967 | APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | 1 |
| 1659960 | APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11673-540-06 | daytime severe cold and cough and nighttime severe cold and cough | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | 20 mg | 1 |
| 11673-541-06 | daytime severe cold and cough and nighttime severe cold and cough | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | 650 mg | 1 |
| 11673-542-12 | daytime severe cold and cough and nighttime severe cold and cough | 1 in 1 CARTON | KIT | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11673-540 | DAYTIME SEVERE COLD AND COUGH AND NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [TARGET CORPORATION] | 1 | Unmatched | 20180123_62eec235-431f-4429-b173-d4a9b45a4e36.zip |
| 11673-541 | DAYTIME SEVERE COLD AND COUGH AND NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [TARGET CORPORATION] | 1 | Unmatched | 20180123_62eec235-431f-4429-b173-d4a9b45a4e36.zip |
| 11673-542 | DAYTIME SEVERE COLD AND COUGH AND NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [TARGET CORPORATION] | 1 | Current NDC, Legacy NDC, 3 package rows | 20180123_62eec235-431f-4429-b173-d4a9b45a4e36.zip |
Products#
Every source-derived product name is available through these pages.
- daytime severe cold and cough and nighttime severe cold and cough
- Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Phenylephrine HCl
- daytime severe cold and cough
- ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- FD&C BLUE NO. 1
- ANHYDROUS CITRIC ACID
- MALTODEXTRIN
- POTASSIUM CHLORIDE
- FD&C RED NO. 40
- SILICON DIOXIDE
- SUCRALOSE
- SUCROSE
- nighttime severe cold and cough
- ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- FD&C YELLOW NO. 6
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11673-542 | 11673-542-12 |
| 11673-540 | 11673-540-06 |
| 11673-541 | 11673-541-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| daytime severe cold and cough and nighttime severe cold and cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Target Corporation | 62eec235-431f-4429-b173-d4a9b45a4e36 | 2018-01-18 | Warnings | 11673-542-12 11673-541-06 11673-540-06 11673-542 11673054006 11673054212 11673054106 62eec235-431f-4429-b173-d4a9b45a4e36 62eec235-431f-4429-b173-d4a9b45a4e36 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.