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NDC 68210-1110-01 COLD and FLU 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 Details
COLD and FLU 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
COLD and FLU is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Spirit Pharmaceuticals LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 68210-1110-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 68210-1110-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 68210-1110-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 68210-1110 |
|---|---|
| Product ID | 68210-1110_ee162a3e-f62b-ca93-e053-2a95a90aae2c |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | COLD and FLU |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 325; 10; 200; 5 |
| Active Ingredient Units | mg/1; mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Spirit Pharmaceuticals LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 68210-1110-01 (68210111001)
| NDC Package Code | 68210-1110-1 |
|---|---|
| Billing NDC | 68210111001 |
| Package | 2 BLISTER PACK in 1 CARTON (68210-1110-1) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| Marketing Start Date | 2020-03-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8331a2a9-0857-4b64-bfb5-4f8c728e66f6 Details
SPL UNCLASSIFIED SECTION
Uses
- temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- minor aches & pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 softgels in 24 hours, which is the maximum daily amount for this product
- 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
- 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 enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
Directions
- do not take more than directed - see Overdose warning
- do not exceed 12 softgels in any 24 hour period
- adults and children 12 years of age and over: take 2 softgels every 4 hours
- children under 12 years of age: do not use
Inactive ingredients
Principal Display Panel
Compare to active ingredients in Maximum Strength MUCINEX® FAST-MAX® COLD & FLU ALL IN ONE*
MAXIMUM STRENGTH
Cold & Flu
ACETAMINOPHEN/ PAIN RELIEVER/ FEVER REDUCER
DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT
GUAIFENESIN/ EXPECTORANT
PHENYLEPHRINE HCL/NASAL DECONGESTANT
DISSOLVES QUICKLY
Temporarily Relieves headache, fever, sore throat,
minor aches & pains, cough, chest congestion,
nasal/sinus congestion & sinus pressure
16 SOFTGELS
For Ages 12+
INGREDIENTS AND APPEARANCE
| COLD AND FLU
acetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled |
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| Labeler - Spirit Pharmaceuticals LLC (179621011) |
| Registrant - Spirit Pharmaceuticals LLC (179621011) |