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
ShopRite DayTime Flu Plus Severe Cold And Cough
- Manufacturer
- WAKEFERN FOOD CORPORATION
- Effective date
- 2015-01-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:41:37
Label at a glance#
ProductShopRite DayTime Flu Plus Severe Cold And Cough
Active ingredientAcetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
Label structure10 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 children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink ...
Storage and handling
each packet contains: potassium 4 mg, sodium 27 mg phenylketonurics: contains phenylalanine 34 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each packet) | Purposes |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan hydrobromide 20 mg | Cough suppressant |
| Phenylephrine hydrochloride 10 mg | 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
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.
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
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 4 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 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 a 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
- 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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health care professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. 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 take more than 5 packets in 24 hours unless directed by a doctor
| Age | Dose |
|---|---|
| children under 4 years of age | do not use |
| children 4 to under 12 years of age | do not use unless directed by a doctor |
| adults and children 12 years of age and over | one packet |
- 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
- each packet contains: potassium 4 mg, sodium 27 mg
- phenylketonurics: contains phenylalanine 34 mg per packet
- store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.
Inactive ingredients
acesulfame potassium, aspartame, citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch.
Questions or Comments?
Call 1-800-ShopRite
SPL UNCLASSIFIED SECTION
Distributed By: Wakefern Food Corp.
5000 Riverside Drive
Keasbey, NJ 08832
PRINCIPAL DISPLAY PANEL - 6 Packet Carton
Compare to: Active Ingredients in Theraflu® Daytime Severe Cold & Cough
See New Warnings
Information & Directions
ShopRite®
Daytime
FLU & SEVERE
COLD & COUGH
ACETAMINOPHEN
Pain Reliever/Fever Reducer
DEXTROMETHORPHAN HBr
Cough Suppressant
PHENYLEPHRINE HCl
Nasal Decongestant
Nasal & Sinus Congestion, Cough, Body Ache,
Sore Throat Pain, Headache, Fever
Berry Infused
with Menthol & Green Tea Flavor
6 PACKETS
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 | 1 |
| 1659967 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | 1 |
| 1659967 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 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 |
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 |
|---|---|---|---|---|---|
| 41190-112-07 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0993-f424-e053-dadaa90a57ce | ShopRite ® DayTime Flu + Severe Cold & Cough |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41190-112-07 | ShopRite DayTime Flu Plus Severe Cold And Cough | 5 in 1 CARTON | POWDER, FOR SOLUTION | 5 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41190-112 | SHOPRITE DAYTIME FLU PLUS SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAKEFERN FOOD CORPORATION] | 1 | Legacy NDC, 1 package rows | 20150204_4aeb7f40-b315-48e4-97dc-237d06d0f2d4.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Dextromethorphan hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Phenylephrine hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| acesulfame potassium | INACTIVE INGREDIENT | 23OV73Q5G9 | 1 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| anhydrous trisodium citrate | INACTIVE INGREDIENT | RS7A450LGA | 1 | |
| aspartame | INACTIVE INGREDIENT | Z0H242BBR1 | 1 | |
| FD&C blue no. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| maltodextrin | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- ShopRite DayTime Flu Plus Severe Cold And Cough
- Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
- Acetaminophen
- Dextromethorphan hydrobromide
- Dextromethorphan
- Phenylephrine hydrochloride
- Phenylephrine
- acesulfame potassium
- aspartame
- anhydrous citric acid
- FD&C blue no. 1
- FD&C red no. 40
- maltodextrin
- anhydrous trisodium citrate
- sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41190-112 | 41190-112-07 |
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 |
| acesulfame potassium | 23OV73Q5G9 | IACT |
| aspartame | Z0H242BBR1 | IACT |
| anhydrous citric acid | XF417D3PSL | IACT |
| FD&C blue no. 1 | H3R47K3TBD | IACT |
| FD&C red no. 40 | WZB9127XOA | IACT |
| maltodextrin | 7CVR7L4A2D | IACT |
| anhydrous trisodium citrate | RS7A450LGA | IACT |
| sucrose | C151H8M554 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION/ DROPS / AURICULAR (OTIC) | 1 mg | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | GRANULE, FOR SUSPENSION / ORAL | 952 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | SYRUP / ORAL | 3 mg | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | PASTE / ORAL | 1050 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 78 mg | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | POWDER, FOR SUSPENSION / ORAL | 8000 mg | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | TABLET / SUBLINGUAL | 36 mg | ||
| acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | POWDER, FOR SOLUTION / ORAL | 117 mg | ||
| sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | SHAMPOO / TOPICAL | 2 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | POWDER, FOR SUSPENSION / ORAL | 320 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM / SUBLINGUAL | 11 mg | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 240 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | POWDER, FOR SOLUTION / ORAL | 123 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INTRACARDIAC | 25 mg | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | INJECTION / INTRABURSAL | 1 %w/v | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INTRAMUSCULAR | 101 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | TABLET / ORAL | 87 mg | ||
| acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, CHEWABLE / ORAL | 15 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | SUSPENSION / ORAL | 23 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | SUSPENSION / ORAL | 6040 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | TABLET, FOR SUSPENSION / ORAL | 15 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | SUSPENSION / ORAL | 21 mg | ||
| sucrose | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| sucrose | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| sucrose | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / OPHTHALMIC | 0.09 %w/v | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / TOPICAL | 4.35 %w/v | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | GRANULE, EFFERVESCENT / ORAL | 935 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / INTRAVENOUS | ADJ PH | ||
| sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EFFERVESCENT / ORAL | 840 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | GEL / TOPICAL | 3 mg | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | TABLET, EXTENDED RELEASE / ORAL | 3239 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, ORALLY DISINTEGRATING / ORAL | 46 mg | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | FILM / SUBLINGUAL | 4 mg | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | TABLET, CHEWABLE / ORAL | 292 mg | ||
| acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | FILM / SUBLINGUAL | 5 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EXTENDED RELEASE / ORAL | 312 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, EFFERVESCENT / ORAL | 4 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 414 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | GRANULE, FOR SUSPENSION / ORAL | 30 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | SOLUTION / ORAL | 40 mg | ||
| sucrose | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | POWDER, FOR SOLUTION / ORAL | 48 mg/5ml |
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 |
|---|---|---|---|---|---|---|
| 3fab182d-ff94-4826-9d35-b2760f776dd2 | 4aeb7f40-b315-48e4-97dc-237d06d0f2d4 | 2015-01-29 | Warnings | 3fab182d-ff94-4826-9d35-b2760f776dd2 4aeb7f40-b315-48e4-97dc-237d06d0f2d4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.