FDA Label for Up And Up Daytime Nighttime Childrens Multi Symptom Cold
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- LIVER WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OVERDOSE WARNING
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - KIT CARTON
Up And Up Daytime Nighttime Childrens Multi Symptom Cold Product Label
The following document was submitted to the FDA by the labeler of this product Target Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Day Time Multi-Symptom Cold
DO NOT TAKE BOTH PRODUCTS WITHIN 4 HOURS OF EACH OTHER
Drug Facts
Nighttime Children’s Multi-Symptom Cold
DO NOT TAKE BOTH PRODUCTS WITHIN 4 HOURS OF EACH OTHER
Drug Facts
Dist. by: Target Corporation
Minneapolis, MN 55403
Made In the U.S.A.
With domestic and imported ingredients.
TM & © 2024 Target Brands, Inc.
Otc - Purpose
Active ingredients (in each 5 mL) | Purposes |
---|---|
Dextromethorphan HBr 5 mg | Cough suppressant |
Guaifenesin 100 mg | Expectorant |
Phenylephrine HCl 2.5 mg | Nasal decongestant |
Active ingredients (in each 10 mL) | Purposes |
---|---|
Acetaminophen 325 mg | Pain reliever/fever reducer |
Diphenhydramine HCl 12.5 mg | Antihistamine/cough suppressant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- nasal congestion due to a cold
- stuffy nose
- temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- runny nose
- sneezing
- cough
- controls cough to help your child get to sleep
- temporarily reduces fever
Otc - Do Not Use
Do not usein a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Otc - Ask Doctor
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Otc - When Using
When using this productdo not use more than directed
Otc - Stop Use
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
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.
Keep out of reach of children.
Directions
- do not give more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see Overdose warning)
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours; do not give more than 5 doses in any 24-hour period
- children under 6 years of age: do not use
Age | Dose |
---|---|
children 6 years to under 12 years | 10 mL every 4 hours |
children 4 years to under 6 years | 5 mL every 4 hours |
children under 4 years | do not use |
Other Information
- each 5 mL contains:sodium 2 mg
- store at room temperature
- do not refrigerate
- dosing cup provided
- each 10 mL contains:sodium 4 mg
- store at room temperature
- do not refrigerate
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C Blue No.1, FD&C Red #40, flavors, potassium citrate, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, potassium citrate, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-866-467-2748
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- Skin reddening
- Blisters
- Rash
Allergy alert:Acetaminophen may cause severe skin reactions.
Symptoms may include:
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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- to make a child sleepy
- with any other drug containing diphenhydramine, even one used on the skin
- in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask A Doctor Before Use If Your Child Has
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- glaucoma
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If Your Child Is
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product
- do not use more than directed (see Overdose warning)
- excitability may occur, especially in children
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 5 days
- fever gets worse, or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Overdose Warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Questions?
1-866-467-2748.
Principal Display Panel - Kit Carton
VALUE
PACK
Compare to active ingredients in Children’s Mucinex® Multi-Symptom Cold* and Children’s Mucinex® Nighttime Multi-Symptom Cold**
NDC 82442-476-08
Daytime Nighttime Children’s Multi-Symptom Cold
Dextromethorphan HBr 5 mg (Cough Suppressant)
Guaifenesin 100 mg (Expectorant)
Phenylephrine HCl 2.5 mg (Nasal Decongestant)
- Breaks up Mucus
- Provides relief from stuffy nose, cough and chest congestion
- Provides relief from sneezing, stuffy or runny nose, cough, fever and sore throat
Age 4 to 11 Years
Dosage Cup Included
Berry Flavor
NATURALLY AND ARTIFICIALLY FLAVORED
4 FL OZ (118 mL)
NIGHTTIME
Multi-Symptom
Cold
Acetaminophen 325 mg(Pain Reliever/Fever Reducer)
Diphenhydramine HCl 12.5 mg (Antihistamine/Cough Suppressant)
Phenylephrine HCl 5 mg (Nasal Decongestant)
Very Berry Flavor
NATURALLY AND ARTIFICIALLY FLAVORED
Ages 6 to 11 years
Dosage Cup Included
4 FL OZ (118 mL)
8 FL OZ (236 mL) TOTAL
* This product is not manufactured or distributed by RB Health (US), distributor of Children’s Mucinex® Multi-Symptom Cold.
**This product is not manufactured or distributed by RB Health (US), distributor of Children’s Mucinex® Nighttime Multi-Symptom Cold.
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING.
Important: Keep this carton for future reference for full labeling.
* Please review the disclaimer below.