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
Severe Cold and Cough Daytime
- Manufacturer
- Chain Drug Manufacturing Assn
- Effective date
- 2022-01-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:47:08
Label at a glance#
ProductSevere Cold and Cough Daytime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
▪ do not use more than directed ▪ take every 4 hours; while symptoms persist. Do not to exceed 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 8 ...
Storage and handling
▪ each packet contains: potassium 6mg ▪ store at room temperature. Protect from excessive heat and moisture.
Contacts and useful links#
Websitewww.qualitychoice.com
www.qualitychoice.com
www.qualitychoice.comLabel contents#
Full prescribing information#
Active ingredients (in each packet)
Acetaminophen 650 mg
Dextromethorphan hydrobromide 20 mg
Phenylephrine hydrochloride 10 mg
Purposes
Pain reliever / fever reducer
Cough Suppressant
Nasal Decongestant
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
Warnings
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
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.
Do not use
- 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.
Ask doctor before use if you have
- 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 or pharmacist before use if you are
- taking the blood thinning drug warfarin
When using this product
- do not exceed recommended dosage
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- symptoms do not get better or worsen
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs fever, rash or headache that lasts. These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health care professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away at 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
- do not use more than directed
- take every 4 hours; while symptoms persist. Do not to exceed 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 8 oz. of cool water: Stir briskly before and after heating: Do not overheat.
Other information
- each packet contains: potassium 6mg
- store at room temperature. Protect from excessive heat and moisture.
Inactive ingredients
citric acid, FD &C blue # 1, FD & C red # 40,flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose
Questions or Comments?
1-866-467-2748
Principal Display
QC Quality Choice
*Compare to the Active Ingredients in Theraflu® Daytime Severe Cold &Cough
SEVERE COLD & COUGH
Daytime
Acetaminophen
Pain Reliever/ Fever Reducer
Dextromethorphan HBr
Cough suppressant
Phenylephrine HCl
Nasal Decongestant
Aspartame Free ●Sodium Free
Relieves:
- Nasal Congestion
- Cough/Body Ache
- Sore Throat Pain
- Headache/Fever
Berry Infused with Menthol & Green Tea Flavors
6 Packets
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE, KEEP CARTON FOR REFERENCE, DO NOT DISCARD, |
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Daytime Severe Cough & Cold
TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.
Distributed by: C.D.M.A., Inc
43157 W. 9 Mile Rd
Novi, MI 48375
Questions: 248-449-9300
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1659967 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | 3 |
| 1659967 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | 3 |
| 1659967 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral Solution | SY | 3 |
| 1659967 | APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63868-290-06 | 2024-01-30 | C162847 | 48780-1 | ba0f9c33-3243-a910-e053-dadaa90a0b85 | QC Quality Choice Severe Cold and Cough Daytime Berry infused with Menthol and Green Tea Flavors 6 Packets |
| 63868-290-06 | 2022-01-18 | C162847 | 48780-1 | ba0f9c33-3243-a910-e053-dadaa90a0b85 | QC Quality Choice Severe Cold and Cough Daytime Berry infused with Menthol and Green Tea Flavors 6 Packets |
| 63868-290-06 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3243-a910-e053-dadaa90a0b85 | QC Quality Choice Severe Cold and Cough Daytime Berry infused with Menthol and Green Tea Flavors 6 Packets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-290-06 | Severe Cold and Cough Daytime | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | 3 | |
| 63868-290-06 | Severe Cold and Cough Daytime | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63868-290 | SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [CHAIN DRUG MANUFACTURING ASSN] | 3 | Legacy NDC, 2 package rows | 20220119_26d2d39a-6d37-45d9-a4f9-4015cc97158b.zip |
Products#
Every source-derived product name is available through these pages.
- Severe Cold and Cough Daytime
- ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- MALTODEXTRIN
- POTASSIUM CHLORIDE
- SILICON DIOXIDE
- SUCRALOSE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63868-290 | 63868-290-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| POTASSIUM CHLORIDE | 660YQ98I10 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SUCROSE | C151H8M554 | IACT |
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 |
|---|---|---|---|---|---|---|
| 3c291770-4524-474a-ad3f-4fc34416f754 | 26d2d39a-6d37-45d9-a4f9-4015cc97158b | 2022-01-18 | Warnings | 3c291770-4524-474a-ad3f-4fc34416f754 26d2d39a-6d37-45d9-a4f9-4015cc97158b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.