Up & Up
df488727-b913-440b-9a0b-cce3ae143bf2
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Description
Drug Facts
Uses
- 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
Section 42229-5
Drug Facts
Section 50565-1
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.
Section 50568-5
Ask a doctor or pharmacist before use if you aretaking
- sedatives or tranquilizers
- the blood thinning drug warfarin
Section 53414-9
If pregnant or breast-feeding,ask a heath care professional before use.
Section 55105-1
| Active ingredients (in each packet) | Purposes |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Diphenhydramine hydrochloride 25 mg | Antihistamine/cough suppressant |
| Phenylephrine hydrochloride 10 mg | Nasal decongestant |
Directions
- do not use more than directed
- take every 4 hours; 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.
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.
- with any other product containing diphenhydramine, even one used on the 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 an MAOI, ask a doctor or pharmacist before taking 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.
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
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.
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.
Inactive Ingredients
acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch.
Questions Or Comments?
Call 1-800-910-6874
When Using This Product
- 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
- 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 with fever, rash or headache that lasts. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema, asthma 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
Principal Display Panel 6 Packet Carton
See new warnings information & directions
NDC 11673-113-07
Compare toactive ingredients in
Theraflu
®
Nighttime Severe Cold & Cough*
nighttime
severe cold,
cough and flu
acetaminophen (pain reliever/fever reducer)
diphenhydramine HCl (antihistamine/cough suppressant)
phenylephrine HCl (nasal decongestant)
nasal congestion, cough,
runny nose, sneezing,
body ache, sore throat pain,
headache, fever
honey lemon infused
with chamomile and
white tea flavors
up & up
HONEY
LEMON
FLAVOR
6
PACKETS
6 PACKETS
Structured Label Content
Uses
- 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
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
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.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you aretaking
- sedatives or tranquilizers
- the blood thinning drug warfarin
Section 53414-9 (53414-9)
If pregnant or breast-feeding,ask a heath care professional before use.
Section 55105-1 (55105-1)
| Active ingredients (in each packet) | Purposes |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Diphenhydramine hydrochloride 25 mg | Antihistamine/cough suppressant |
| Phenylephrine hydrochloride 10 mg | Nasal decongestant |
Directions
- do not use more than directed
- take every 4 hours; 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.
Do Not Use (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.
- with any other product containing diphenhydramine, even one used on the 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 an MAOI, ask a doctor or pharmacist before taking this product.
Allergy Alert (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 (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
Other Information (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.
Sore Throat Warning (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.
Inactive Ingredients (Inactive ingredients)
acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch.
Questions Or Comments? (Questions or Comments?)
Call 1-800-910-6874
When Using This Product (When using this product)
- 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 (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 with fever, rash or headache that lasts. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema, asthma 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
Principal Display Panel 6 Packet Carton (PRINCIPAL DISPLAY PANEL - 6 Packet Carton)
See new warnings information & directions
NDC 11673-113-07
Compare toactive ingredients in
Theraflu
®
Nighttime Severe Cold & Cough*
nighttime
severe cold,
cough and flu
acetaminophen (pain reliever/fever reducer)
diphenhydramine HCl (antihistamine/cough suppressant)
phenylephrine HCl (nasal decongestant)
nasal congestion, cough,
runny nose, sneezing,
body ache, sore throat pain,
headache, fever
honey lemon infused
with chamomile and
white tea flavors
up & up
HONEY
LEMON
FLAVOR
6
PACKETS
6 PACKETS
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:06:31.739453 · Updated: 2026-03-14T23:09:21.323328