| Active ingredients (in each caplet) (Daytime) | Purpose |
| Acetaminophen 325mg | Pain Reliever |
| Guaifenesin 200mg | Expectorant |
| Phenylephrine HCl 5mg | Nasal Decongestant |
| Active ingredients (in each caplet) (Nighttime) | Purpose |
| Acetaminophen 325mg | Pain Reliever |
| Diphenhydramine 12.5mg | Anthistamine/Cough suppressant |
| Phenylephrine HCl 5mg | Nasal Decongestant |
Daytime
Pain reliever, Expectorant and Nasal decongestant
Nighttime
Pain reliever, Antihistamine/cough suppressant and Nasal decongestant
* temporarily relieves:
* temporarily promotes nasal and/or sinus drainag
* helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
*more than 12 caplets in 24 hrs, which is the maximum daily amount
* 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.
Do not use
*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 have ever had an allergic reaction to this product or any of its ingredients
* with any other drug containing diphenhydramine, even one used on the skin (Nighttime only)
* 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
* diabetes
* high blood pressure
* thyroid disease
* trouble urinating due to an enlarged prostate gland
* glaucoma (Nighttime only)
* a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
* persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
* cough that occurs with too much phlegm (mucus)
Ask a doctor or a pharmacist before use if you are
* taking the blood thinning drug warfarin
* taking sedatives or tranquilizers (Nighttime only)
When using this product
* do not exceed recommended dose
* excitability may occur, especially in children (Nighttime only)
* marked drowsiness may occur (Nighttime only)
* alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
* be careful when driving a motor vehicle or operating machinery (Nighttime only)
* avoid alcoholic beverages (Nighttime only)
Stop use and ask a doctor if
* nervousness, dizziness, or sleeplessness occur
* pain, nasal congestion, or cough gets worse or lasts more than 7 days
* new symptoms occur
* fever gets worse or lasts more than 3 days
* redness or swelling is present
* 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 accidental 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.
If taking Nighttime and Daytime products,
carefully read each section to ensure correct dosing
Do not take
DAYTIME and
NIGHTTIME at the same time
Keep out of reach of children
In case of accidental 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
* swallow whole with a glass of water; do not crush, chew or dissolve
* do not take more than 12 caplets in 24 hours
| adults and children 12 years of age and over | take 2 caplets every 4 hours |
| children under 12 years of age | do not take |
Other information
* each Nighttime caplet contains: Calcium 40mg or less
* store at room temperature 25°C (77°F) ; excursions permitted between 15°C - 30°C (59°F -86°F)
Inactive ingredients (Daytime)
microcrystalline cellulose, dibasic calcium phosphate, croscarmellose sodium, talc, colloidal silicon dioxide, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide,FD&C yellow #6, FD&C red #40, gelatin, starch, polyvinyl povidone, maltodextrin, sodium starch glycolate
Inactive ingredients (Nightime)
microcrystalline cellulose, dibasic calcium phosphate, corn starch, croscarmellose sodium, talc, colloidal silicon dioxide, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glyocol, mica, titanium dioxide, FD&C blue #1, methacrylic acid copolymer, FD&C blue #2, sodium bicarbonate, starch, gelatin, sodium starch glycolate
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2634398 | {1 (acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } Pack | GPCK | 3 |
| 1233575 | acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 3 |
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 3 |
| 2634398 | daytime 1 (acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / nighttime 1 (acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet) Pack | PSN | 3 |
| 1233575 | acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 3 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 3 |
| 1233575 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet | SY | 3 |
| 1233575 | APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 3 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 3 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 3 |
| 2634398 | daytime 1 (acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / nighttime 1 (acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet) Pack | SY | 3 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70692-103-12 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b345-a426-e053-dadaa90af4c2 | MULTI-SYMPTOM SINUS RELIEF PAIN & CONGESTION MAXIMUM STRENGTH DAYTIME AND NIGHTTIME |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70692-103-12 | Multi Symptom Sinus Relief Pain and Congestion Daytime Nighttime | 1 in 1 PACKAGE, COMBINATION | KIT | 1 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70692-103 | MULTI SYMPTOM SINUS RELIEF PAIN AND CONGESTION DAYTIME NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [STRIVE PHARMACEUTICALS INC.] | 3 | Legacy NDC, 1 package rows | 20201117_67dcb6fa-c14b-8413-e053-2991aa0a4ace.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70692-103 | 70692-103-12 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| b43d1b61-3f0b-4cb0-e053-2995a90a4409 | 67dcb6fa-c14b-8413-e053-2991aa0a4ace | 2020-11-16 | Warnings | b43d1b61-3f0b-4cb0-e053-2995a90a4409 67dcb6fa-c14b-8413-e053-2991aa0a4ace |
Adverse event summaries are temporarily unavailable. Other product information remains available.